BACKGROUND: Few studies have investigated the use of dexmedetomidine in patients with a high risk of postoperative nausea and vomiting (PONV) following gynaecological laparoscopic surgery. OBJECTIVE: To investigate if the intra-operative use of dexmedetomidine could reduce the incidence of PONV in this patient population. DESIGN: A randomised, double-blind, placebo-controlled trial. SETTING:A tertiary hospital in Beijing, China. PATIENTS: 130 adult patients scheduled forgynaecological laparoscopic surgery. INTERVENTIONS: Patients in the dexmedetomidine group (Dex group, n = 65) received a loading dose of dexmedetomidine (0.5 μg kg over 10 min) before induction of anaesthesia, followed by a continuous infusion (0.1 μg kg h) until the end of surgery. Patients in the control group (Ctrl group, n = 65) received volume-matched normal saline. Propofol and remifentanil were used for induction and maintenance of anaesthesia. Intravenous patient-controlled analgesia with morphine was provided after surgery. MAIN OUTCOME MEASURES: The incidence of 24-h PONV. RESULTS: The incidence of nausea within the first 2 postoperative hours was lower in the Dex group than in the Ctrl group [0% (0/65) vs. 9% (6/65), P = 0.037]. The overall incidence of PONV within the first 2 postoperative hours was slightly lower in the Dex group than in the Ctrl group, but the difference was not statistically significant [5% (3/65) vs. 14% (9/65), P = 0.069]. There was no significant difference between the two groups regarding the incidence of 24-h PONV. CONCLUSION: For adult patients undergoinggynaecological laparoscopic surgery, supplemental use of dexmedetomidine during general anaesthesia reduced the incidence of early postoperative nausea but not vomiting within the 24 h after surgery. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-IPR-15006914.
RCT Entities:
BACKGROUND: Few studies have investigated the use of dexmedetomidine in patients with a high risk of postoperative nausea and vomiting (PONV) following gynaecological laparoscopic surgery. OBJECTIVE: To investigate if the intra-operative use of dexmedetomidine could reduce the incidence of PONV in this patient population. DESIGN: A randomised, double-blind, placebo-controlled trial. SETTING: A tertiary hospital in Beijing, China. PATIENTS: 130 adult patients scheduled for gynaecological laparoscopic surgery. INTERVENTIONS:Patients in the dexmedetomidine group (Dex group, n = 65) received a loading dose of dexmedetomidine (0.5 μg kg over 10 min) before induction of anaesthesia, followed by a continuous infusion (0.1 μg kg h) until the end of surgery. Patients in the control group (Ctrl group, n = 65) received volume-matched normal saline. Propofol and remifentanil were used for induction and maintenance of anaesthesia. Intravenous patient-controlled analgesia with morphine was provided after surgery. MAIN OUTCOME MEASURES: The incidence of 24-h PONV. RESULTS: The incidence of nausea within the first 2 postoperative hours was lower in the Dex group than in the Ctrl group [0% (0/65) vs. 9% (6/65), P = 0.037]. The overall incidence of PONV within the first 2 postoperative hours was slightly lower in the Dex group than in the Ctrl group, but the difference was not statistically significant [5% (3/65) vs. 14% (9/65), P = 0.069]. There was no significant difference between the two groups regarding the incidence of 24-h PONV. CONCLUSION: For adult patients undergoing gynaecological laparoscopic surgery, supplemental use of dexmedetomidine during general anaesthesia reduced the incidence of early postoperative nausea but not vomiting within the 24 h after surgery. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-IPR-15006914.