BACKGROUND: There is still controversy regarding the optimal strategy for managing postoperative nausea and vomiting (PONV) in high-risk surgical populations. Although acustimulation at the P6 acupoint has been demonstrated to be effective in preventing PONV, the effect of this nonpharmacologic therapy on the patient's recovery with respect to resumption of normal activities of daily living has not been previously assessed when it is used as part of a multimodal antiemetic regimen. Therefore, we designed this randomized, sham-controlled, and double-blind study to assess the efficacy of a disposable acupressure device (Pressure Right®; Pressure Point Inc., Grand Rapids, MI) on the incidence of emetic episodes and quality of recovery when used in combination with ondansetron and dexamethasone for antiemetic prophylaxis. METHODS:One hundred ASA physical status I and II patients undergoing major laparoscopic procedures were randomly assigned to either a control group (n = 50) receiving a "sham" acustimulation device or an acupressure group (n = 50) receiving a disposable Pressure Right device placed bilaterally at the P6 point 30 to 60 minutes before induction of anesthesia. All patients received a standardized general anesthetic. A combination of ondansetron, 4 mg IV, and dexamethasone, 4 mg IV, was administered during surgery for antiemetic prophylaxis in both study groups. The incidence of nausea and vomiting and the need for "rescue" antiemetic therapy were assessed at specific time intervals for up to 72 hours after surgery. The recovery profiles and quality of recovery questionnaires were evaluated at 48 hours and 72 hours after surgery. Patient satisfaction with the management of their PONV was assessed at the end of the 72-hour study period. RESULTS: The 2 study groups did not differ in their demographic characteristics or risk factors for PONV. The incidence of vomiting at 24 hours was significantly decreased in the acupressure group (10% vs 26%, P = 0.04, 95% confidence interval for absolute risk reduction 1%-31%). The overall incidence of vomiting from 0 to 72 hours after surgery was also significantly decreased from 30% to 12% in the acupressure group (P = 0.03, 95% confidence interval 2%-33%). Furthermore, adjunctive use of the acupressure device seemed to enhance patient satisfaction with their PONV management and quality of recovery at 48 hours after surgery. However, the recovery times to hospital discharge, resumption of normal physical activities, and return to work did not differ significantly between the 2 study groups. CONCLUSION: Use of the Pressure Right acupressure device in combination with antiemetic drugs provided a reduction in the incidence of vomiting from 0 to 72 hours after surgery with an associated improvement in patient satisfaction with their PONV management. However, recovery and outcome variables failed to demonstrate any improvement with the addition of the acupressure device.
RCT Entities:
BACKGROUND: There is still controversy regarding the optimal strategy for managing postoperative nausea and vomiting (PONV) in high-risk surgical populations. Although acustimulation at the P6 acupoint has been demonstrated to be effective in preventing PONV, the effect of this nonpharmacologic therapy on the patient's recovery with respect to resumption of normal activities of daily living has not been previously assessed when it is used as part of a multimodal antiemetic regimen. Therefore, we designed this randomized, sham-controlled, and double-blind study to assess the efficacy of a disposable acupressure device (Pressure Right®; Pressure Point Inc., Grand Rapids, MI) on the incidence of emetic episodes and quality of recovery when used in combination with ondansetron and dexamethasone for antiemetic prophylaxis. METHODS: One hundred ASA physical status I and II patients undergoing major laparoscopic procedures were randomly assigned to either a control group (n = 50) receiving a "sham" acustimulation device or an acupressure group (n = 50) receiving a disposable Pressure Right device placed bilaterally at the P6 point 30 to 60 minutes before induction of anesthesia. All patients received a standardized general anesthetic. A combination of ondansetron, 4 mg IV, and dexamethasone, 4 mg IV, was administered during surgery for antiemetic prophylaxis in both study groups. The incidence of nausea and vomiting and the need for "rescue" antiemetic therapy were assessed at specific time intervals for up to 72 hours after surgery. The recovery profiles and quality of recovery questionnaires were evaluated at 48 hours and 72 hours after surgery. Patient satisfaction with the management of their PONV was assessed at the end of the 72-hour study period. RESULTS: The 2 study groups did not differ in their demographic characteristics or risk factors for PONV. The incidence of vomiting at 24 hours was significantly decreased in the acupressure group (10% vs 26%, P = 0.04, 95% confidence interval for absolute risk reduction 1%-31%). The overall incidence of vomiting from 0 to 72 hours after surgery was also significantly decreased from 30% to 12% in the acupressure group (P = 0.03, 95% confidence interval 2%-33%). Furthermore, adjunctive use of the acupressure device seemed to enhance patient satisfaction with their PONV management and quality of recovery at 48 hours after surgery. However, the recovery times to hospital discharge, resumption of normal physical activities, and return to work did not differ significantly between the 2 study groups. CONCLUSION: Use of the Pressure Right acupressure device in combination with antiemetic drugs provided a reduction in the incidence of vomiting from 0 to 72 hours after surgery with an associated improvement in patient satisfaction with their PONV management. However, recovery and outcome variables failed to demonstrate any improvement with the addition of the acupressure device.
Authors: Gildasio S De Oliveira; Paul Fitzgerald; Shireen Ahmad; John Kim; Rohit Rahangdale; Robert McCarthy Journal: World J Gastrointest Surg Date: 2014-02-27