Comparison of Hemodynamic Changes in Patients Undergoing Laparoscopic Cholecystectomy using rocuronium and vecuronium for Intubation and Maintenance under General Anesthesia.

Context: The context of the study is to compare and find better muscle relaxant between rocuronium and vecuronium for intubation and maintenance under general anesthesia in patients undergoing laparoscopic cholecystectomy. Aims: The aim of the study is to measure intubating condition, hemodynamic changes during intubation and also during maintenance of general anesthesia and to record complications, if any. Settings and Design: A prospective clinical study conducted in the Department of Anesthesiology in tertiary care center. Materials and
Methods: A total of 100 patients of the American Society of Anesthesiologists Classes Grade I and II were planned for laparoscopic cholecystectomy were divided into two groups of 50 each. The subjects in the control and study group were put under anesthesia using injection propofol 2.0 mg.kg-1 along with injection vecuronium 0.10 mg.kg-1 and injection propofol 2.0 mg.kg-1 along with injection rocuronium 0.60 mg.kg-1, respectively. Hemodynamic monitoring and oxygen saturation (SPO2) were recorded at various intervals. Statistical Analysis Used: All the collected data were imported into Microsoft Excel, and the statistical analysis was done by using SPSS 25.0 version.
Results: The mean heart rate before and after carboperitoneum at different time intervals and before and after extubation was significantly lower in vecuronium group. The mean systolic blood pressure and mean arterial pressure at 1 and 5 minutes after extubation were significantly more among vecuronium group. Conclusions: Rocuronium is reasonably cardiostable, produces excellent intubation conditions, has a shorter duration of action, and shows minimal cumulative effect. Copyright:

INTRODUCTION

Laparoscopic cholecystectomy is a gold standard procedure for the management of gall bladder stones and is usually performed under general anesthesia. The procedure provides various advantages over open technique: reduces stress response to surgery, decreases pain postoperatively, reduces the incidence of wound infection, and hastens recovery along with better cosmetic results.[12] Intra-abdominal pressure is increased due to gas insufflation which causes venous compression resulting in decreased preload.

Major drawbacks seen are a result of physiological effects of insufflation of CO2 in the abdomen. Carboperitoneum can cause hypercapnia which can lead to tachycardia and rise in blood pressure and causes dysarrythmias due to sympathetic activation.[3] Any change in the respiratory system due to carboperitoneum will cause decrease in lung volumes and capacities, increase in peak airway pressure, and increase incidence of mismatched ventilation to perfusion ratio, pneumomediastinum, and pneumothorax.[4]

Rocuronium, a nondepolarizing muscle relaxant known for having a faster onset of action and duration of action, is intermediate.[5] Rocuronium is similar to vecuronium in structure and properties. The major advantage of rocuronium is faster onset and excretion without any change in urine, hence eliminating the side effects caused by the metabolites.[6] Vecuronium is known to cause decrease in the heart rate (HR) and can even lead to arrest in a few subjects after insufflation of CO2 in the peritoneum under general anesthesia where O2 along with halothane is used for the maintenance of anesthesia. Rocuronium bromide has proven to provide stable hemodynamic conditions during general anesthesia where the maintenance of anesthesia is managed similarly.[7] The current study compared and noted the hemodynamic changes in patients undergoing laparoscopic cholecystectomy using rocuronium and vecuronium for intubation and maintenance under general anesthesia.

MATERIALS AND METHODS

This prospective clinical study was commenced after obtaining permission from Board of Studies and Ethical committee. It was conducted in the Department of Anesthesiology of tertiary care center during the period 2019–2022.

The calculated sample size was 47 patients in each group. Considering the dropouts, the sample size was taken as 50 patients in each group. A seal of approval from Institutional Ethical Committee (IEC) was obtained (TMMC&RC/IEC/19-20/099) ON December 19, 2019. The World Medical Association Declaration of Helsinki (2013) statement of ethical principles was followed to recruit each patient. Written informed consent duly obtained from each and every patient enrolling for the study for intubation and anesthesia. Patients having American Society of Anesthesiologists (ASA) Classes I or II between the age group of 20 and 60 years within body mass index of 18.5–22.9 kg.m−2 posted for laparoscopic cholecystectomy under general anesthesia were included in the study while patients undergoing surgery with moderate-to-severe blood loss, patients allergic to pretreatment or study drugs, patients with anticipated difficult airway, and patients having systemic diseases such as cardio-pulmonary, hepatic, renal or metabolic disorders were excluded from the study. The patients were randomized into two groups using the chit and box method. Group I patients received intravenous rocuronium. Group 2 patients received intravenous vecuronium. After enrolling the patient, a complete medical history along with full general physical examination was done and routine and patient specific investigations were done.

Pre anesthetic evaluation was done for all the patients before surgery. Each patient was explained the entire procedure and purpose in his/her language.

Inside the operation theater, monitors specified by the ASA guidelines such as pulse oximetry, electrocardiogram, and noninvasive blood pressure were attached and vitals were recorded before the procedure. An intravenous line secured with an 18–20 G cannula according to patient/surgery requirements. All the participants were split up into two groups: control group and study group. The participants in the control were put under anesthesia using injection propofol 2.0 mg.kg−1 and injection vecuronium bromide 0.10 mg.kg−1. The study group participants were put under anesthesia using injection propofol 2.0 mg.kg−1 along with injection rocuronium 0.60 mg.kg−1.

The drug was given in a tray after randomization in chit-box method to the person who will give the drug. The anesthesiologist performing the intubation will not be aware of the drug given to the patient. Each patient was mask ventilated with 100% oxygen using Bain's circuit for 3 min and intubated with cuffed endotracheal tube of appropriate size by an experienced senior anesthesiologist. Anesthesia was intraoperatively maintained with O2 and nitrous oxide kept at 66:33% ratio and inhalation agent used was isoflurane in required concentrations to provide deeper plane of anesthesia.

The conditions were evaluated and assessed during intubation and grading was done using Cooper's scoring system.[7] All the collected data were imported into Microsoft Excel, and the statistical analysis was done by using Statistical Package for the Social Science; SPSS Inc. version 25, Armonk, NY: IBM Corp. of statistical software. The qualitative (categorical) variables were presented in the form of frequency and percentage, while the quantitative (numerical) variables were presented in the form of mean and standard deviation. The calculated average values between both the groups were promptly compared using student t-test, while the frequency was compared with the Chi-square test. When P value was less than 0.05, it was considered as statistically significant.

RESULTS

The consort flow diagram represents the assessment to analysis of all patients [Figure 1]. Demographic properties and ASA PS Classification were comparable in both the groups [Table 1].

Figure 1

Consort flow diagram

Table 1

Demographic profile and ASA physical status (PS) of Rocuronium group compared to Vecuronium group

Gender	No. of patients (%)
	Rocuronium group	Vecuronium group
Male	28 (56%)	22 (44%)
Female	22 (44%)	28 (56%)
Total	50	50
c2 value=1.44, P value = 0.0.23
ASA PS	No. of patients (%)
	Rocuronium group	Vecuronium group
ASA I	34 (68%)	37 (74%)
ASA II	16 (32%)	13 (26%)
Total	50	50
c2 value=0.44, P value = 0.66

P-value<0.05 - Significant. ASA: American Society of Anesthesiologists

The mean HR before carboperitoneum, 1 min after carboperitoneum, 1, 5, 10, 15, 20 min after first top up, before extubation, 1 and 5 min after extubation were significantly lower among vecuronium group (P > 0.05) [Table 2].

Table 2

Comparison of heart rate between rocuronium group and vecuronium group

Heart rate	Mean±SD		Mean difference	t-test value	P*
	Rocuronium	Vecuronium
Baseline	76.26±9.44	79.98±4.50	−3.71	−1.301	0.124
After muscle relaxant	78.71±10.51	79.29±3.56	−0.57	−0.334	0.739
Before intubation	80.00±11.53	79.48±10.56	0.52	0.217	0.829
1 min postintubation	86.86±13.20	87.38±6.94	−0.52	1.117	0.205
5 min postintubation	83.12±12.24	83.57±6.60	−0.45	−0.211	0.834
Before skin incision	80.81±8.61	81.05±8.42	−0.24	−0.128	0.898
1 min after skin incision	80.02±12.08	77.90±8.20	2.12	0.941	0.349*
Before carboperitoneum	82.64±9.49	79.79±6.04	2.86	13.16	0.001*
1 min after carboperitoneum	83.52±13.33	77.21±3.77	6.31	12.30	0.001*
1 min after first top up	84.93±7.75	79.74±7.27	5.19	21.45	0.001*
5 min after first top up	88.67±7.73	85.74±7.79	2.93	19.45	0.001*
10 min after first top up	88.24±11.59	82.57±7.18	5.67	12.20	0.001*
15 min after first top up	89.40±14.66	76.24±7.39	13.17	5.197	0.001*
20 min after first top up	82.45±12.63	75.38±8.40	7.07	3.021	0.003*
Before extubation	92.79±6.22	88.02±4.76	4.76	3.941	0.01*
1 min after extubation	96.43±0.50	98.48±8.23	−2.05	−2.061	0.04*
5 min after extubation	86.38±0.94	90.79±8.49	−4.40	−3.343	0.01*

*P<0.05 - Significant. SD=Standard deviation

The mean systolic blood pressure (SBP), mean diastolic blood pressure (DBP), and mean arterial pressure (MAP) at 1 min and 5 min after extubation were significantly more among vecuronium group as compared to rocuronium group [Figure 2].

Figure 2

Comparison of systolic blood pressure, diastolic blood pressure, and mean arterial pressure (mmHg) in both groups

The Chi-square test was used to analyze the distribution of Cooper's score between the rocuronium and vecuronium groups. Cooper's score 8 was significantly more among vecuronium group. Cooper's score 9 was significantly more among rocuronium group [Table 3].

Table 3

Comparison of parameters between rocuronium group and vecuronium group

Parameters	Scores	Groups		Total	χ 2	P*
		Rocuronium	Vecuronium
Jaw relaxation	3	42 (100.0)	42 (100.0)	84 (100.0)	0.001	1.000*
Vocal cords	2	0	29 (69.0)	29 (34.5)	44.291	0.001
3	42 (100.0)	13 (31.0)	55 (65.5)
Response to intubation	3	42 (100.0)	42 (100.0)	84 (100.0)	0.001	1.000*
Cooper’s score	8	0	29 (69.0)	29 (34.5)	44.291	0.001
9	42 (100.0)	13 (31.0)	55 (65.5)

*P<0.05 - Significant

The Chi-square test was used to assess the distribution of adverse effects between the rocuronium and vecuronium groups and found to be insignificant.

DISCUSSION

In the current study, we found that hemodynamic effects of both rocuronium and vecuronium were comparable in both groups except mean HR before induction of cardioperitoneum and 5 min after extubation was lower in vecuronium group as compared to rocuronium group. Rocuronium and vecuronium are both good neuromuscular blocking property having different cardiovascular effects. Vagolytic effect of rocuronium and vagotonic effect of vecuronium supports decreases in HR in vecuronium group and stable HR in rocuronium group in our study.[8] The MAP was significantly higher in vecuronium group at 1 and 5 min after extubation.

Chatrath et al.[9] reported that the changes in hemodynamics were observed 1 min after intubation secondary to the stress response. The HR, SBP, and DBP in Group A (rocuronium) and in Group B (vecuronium) returns to baseline values 5 min postintubation but this was not observed in Group C (succinylcholine) proving that vecuronium and rocuronium used with timing principle can produce minimum change in the vital parameters which is also comparable to our study except for HR which was on lower side in vecuronium group.

In our study, mean MAP at 1 min and 5 min after extubation was significantly more with vecuronium as compared to rocuronium. Mathew et al.[10] found a notable drop in MAP values after 60 s of giving rocuronium. After the decrease in MAP values, there was a gradual increase though in our study and there was no significant drop in MAP.

In our present study, the mean HR before carboperitoneum, 1 min after carboperitoneum, 1, 5, 10, 15, and 20 min after first top up, before extubation, 1 and 5 mins after extubation were significantly lower in vecuronium group as compared to rocuronium. A study conducted by Savargaonkar et al.[11] rise in HR to laryngoscopy and intubation from the baseline was observed in both the groups but rocuronium showed significant increase, although the increase in HR was transient. The hemodynamic changes during intubation were comparable in a study by Mohamed and Sameh[12] study where vecuronium and rocuronium were used for rapid sequence induction in morbidly obese patients in a randomized study. Shah and Kulshrestha[13] also shown that in patients undergoing elective ultrafast-track off-pump coronary artery bypass graft, rocuronium provides good-to-excellent intubating conditions without any significant hemodynamic instability when compared with vecuronium which corroborated with our findings.

The finding of our study is consistent with a study done by Maddineni et al.[14] Our observations are also comparable with the research done by Hudson et al.[15] who used rocuronium at 0.60 mg.kg−1 dose and found no change in Levy et al.[16] conducted a research to measure changes in pulse rate with rocuronium with doses 0.6 mg.kg−1 to 1.2 mg.kg−1 and found no significant change in HR with higher doses even.

Our current study findings are in accordance with the study by Wierda et al.[17] regarding vecuronium not causing any significant change in blood pressure.

In the current study, Cooper's score 8 was significantly more among vecuronium group (69.0%). Cooper's score 9 was significantly more among rocuronium group (100.0%). These showed better results among the rocuronium group, although both the groups had excellent score. Similar to our study, Mirakhur[18] found an increased incidence of better to excellent conditions for intubation when rocuronium dose was upregulated to 0.90 mg.kg−1 Hence, they concluded using higher dose of rocuronium for RSI. The intubation score was also comparable in Mohamed and Sameh[12] study which also corresponded to our study. Virmani et al.[19] also found that rocuronium and vecuronium provided best intubating conditions in their study while assessing the effects of muscle relaxants in patients undergoing valve surgery.

Our study gives us the understanding of hemodynamic effects during intubation and postintubation, before and after induction of carboperitoneum, during extubation in patients undergoing laparoscopic cholecystectomy while using rocuronium and vecuronium as muscle relaxant that may will help us in the selection of most appropriate muscle relaxant for above-mentioned procedure.

Our study did not include invasive hemodynamic monitoring technique which could have given us real time monitoring. Although sample size calculated was statistically significant, increase in sample size could have increased power of study. Our study included only patients having ASA physical status (PS) classes I and II, and hence, cardiac stability of rocuronium in ASA PS classes III and IV and patients with cardiac comorbidity also is not confirmed which calls for further studies. Our study was limited to laparascopic cholecystectomy so it is also a matter of concern whether our results can be extrapolated to other surgeries as well and this also calls for further studies.

CONCLUSIONS

For a short procedures, rocuronium is a good alternative to vecuronium, as the drug is reasonably cardiostable, produces excellent intubation conditions, has a shorter duration of action, and shows minimal cumulative effect.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.