BACKGROUND: Few studies have investigated the use of dexmedetomidine in obstetric anaesthesia. OBJECTIVE: To evaluate the effect of dexmedetomidine combined with sufentanil for patient-controlled analgesia (PCA) after caesarean section under spinal anaesthesia. DESIGN: An interventional, randomised, double-blinded, placebo-controlled clinical study. SETTING: Department of Anaesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. PATIENTS: One hundred and twenty parturients (American Society of Anesthesiologists class 1 or 2) scheduled for elective caesarean delivery under spinal anaesthesia randomly allocated into three groups (n = 40 each). INTERVENTIONS: Group 1: physiological saline bolus after delivery and sufentanil PCA, Group 2: dexmedetomidine bolus (0.5 μg kg) after delivery and sufentanil PCA, Group 3: dexmedetomidine bolus (0.5 μg kg) after delivery and sufentanil with dexmedetomidine PCA (background infusion of 0.045 μg kg h with a bolus of 0.07 μg kg). MAIN OUTCOME MEASURES: The total consumption of sufentanil. Pain scores at rest evaluated with a visual analogue scale (VAS) and Ramsay sedation score (RSS) were recorded at the 4, 8 and 24 h after surgery. The patients' pain threshold (PTh) and pain tolerance threshold (PTTh) were measured before surgery and 1 h after initial study drug administration. Satisfaction scores were collected 24 h after surgery. RESULTS:Sufentanil consumption in group 3 was 43.9 ± 19.2 μg, significantly lower than in group 1 (54.5 ± 23.9 μg) and group 2 (56.3 ± 20.6 μg) (P < 0.05). Compared with group 3, VAS was increased at 4, 8 and 24 h after surgery in groups 1 and 2 (P < 0.05); there was no difference between groups 1 and 2. PTh and PTTh were significantly increased 1 h after drug administration in groups 2 (1.59 ± 0.45, 2.57 ± 0.46 mA) and 3 (1.74 ± 0.37, 2.56 ± 0.48 mA) compared with group 1 (1.49 ± 0.49, 2.42 ± 0.62 mA) (P < 0.05). CONCLUSION: The combination of sufentanil and dexmedetomidine for PCA after caesarean section can reduce sufentanil consumption and improve parturients' satisfaction compared with sufentanil PCA alone. TRIAL REGISTRATION: ChiCTR-TRC-11001442.
RCT Entities:
BACKGROUND: Few studies have investigated the use of dexmedetomidine in obstetric anaesthesia. OBJECTIVE: To evaluate the effect of dexmedetomidine combined with sufentanil for patient-controlled analgesia (PCA) after caesarean section under spinal anaesthesia. DESIGN: An interventional, randomised, double-blinded, placebo-controlled clinical study. SETTING: Department of Anaesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. PATIENTS: One hundred and twenty parturients (American Society of Anesthesiologists class 1 or 2) scheduled for elective caesarean delivery under spinal anaesthesia randomly allocated into three groups (n = 40 each). INTERVENTIONS: Group 1: physiological saline bolus after delivery and sufentanil PCA, Group 2: dexmedetomidine bolus (0.5 μg kg) after delivery and sufentanil PCA, Group 3: dexmedetomidine bolus (0.5 μg kg) after delivery and sufentanil with dexmedetomidine PCA (background infusion of 0.045 μg kg h with a bolus of 0.07 μg kg). MAIN OUTCOME MEASURES: The total consumption of sufentanil. Pain scores at rest evaluated with a visual analogue scale (VAS) and Ramsay sedation score (RSS) were recorded at the 4, 8 and 24 h after surgery. The patients' pain threshold (PTh) and pain tolerance threshold (PTTh) were measured before surgery and 1 h after initial study drug administration. Satisfaction scores were collected 24 h after surgery. RESULTS:Sufentanil consumption in group 3 was 43.9 ± 19.2 μg, significantly lower than in group 1 (54.5 ± 23.9 μg) and group 2 (56.3 ± 20.6 μg) (P < 0.05). Compared with group 3, VAS was increased at 4, 8 and 24 h after surgery in groups 1 and 2 (P < 0.05); there was no difference between groups 1 and 2. PTh and PTTh were significantly increased 1 h after drug administration in groups 2 (1.59 ± 0.45, 2.57 ± 0.46 mA) and 3 (1.74 ± 0.37, 2.56 ± 0.48 mA) compared with group 1 (1.49 ± 0.49, 2.42 ± 0.62 mA) (P < 0.05). CONCLUSION: The combination of sufentanil and dexmedetomidine for PCA after caesarean section can reduce sufentanil consumption and improve parturients' satisfaction compared with sufentanil PCA alone. TRIAL REGISTRATION: ChiCTR-TRC-11001442.