CompletedPhase 4ACTRN12614000703606

Effectiveness of sub hypnotic propofol and dexamethasone in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy.

Effectiveness of sub hypnotic propofol and dexamethasone in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy


Sponsor

Ataturk University

Enrollment

120 participants

Start Date

Jan 1, 2014

Study Type

Interventional

Conditions

Summary

Postoperative nausea and vomiting (PONV) are distressful common side-effects following laparoscopic cholecystectomy (LC) .The reported incidence of PONV is 46–72% in patients undergoing LC if prophylactic antiemetic is not given As an anesthetic agent, propofol is highly effective drug preventing postoperative nausea and vomiting , thus it has been used by a number of anesthesiologist.It was demonstrated that continuous infusion of sub hypnotic propofol prevents PONV in female patients receiving intravenous patient-controlled analgesia . Glucocorticoids have analgesic, anti-inflammatory, immune-modulating and antiemetic effects. But, their effect mechanisms are not fully clarified . Dexamethasone, as an glucocorticoid, has been used as an antiemetic drug in patients receiving chemotherapy for more than 25 years .Several prospective studies have shown that severity of PONV associated with LC is reduced by dexamethasone. The primary aim of this prospective, randomized, double blind, placebo-controlled study was to evaluate the efficacy of dexamethasone and continuous infusion of sub hypnotic propofol to prevent PONV in patients undergoing LC. Secondary aim of this study was to determine the rescue antiemetic and analgesic in the first 24 hours after LC.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria3

  • - 65 years female and male
  • ASA I-II
  • patients undergoing laparoscopic cholecystectomy

Exclusion Criteria7

  • pregnancy
  • use of antiemetic drug 24 hours before LC
  • a history of vomiting and nausea in the previous operations susceptibility to nausea and vomiting
  • menstruation
  • emergency operation
  • severe diabetes mellitus
  • conversion from LC to an laparotomy procedure

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Interventions

A total of 120 ASA physical status I and II were included in this randomized, double-blind, placebo-controlled study. Patients were randomly assigned to 3 groups (n=40) before induction of anesthesia.

A total of 120 ASA physical status I and II were included in this randomized, double-blind, placebo-controlled study. Patients were randomly assigned to 3 groups (n=40) before induction of anesthesia. Patients of group dexamethasone (group D) were administrated 8 mg dexamethasone intravenous infusion before induction of anesthesia. Patients of group propofol (group P) were infused to sub hypnotic (1 mg/kg/h) propofol during operation. Patients of group control (group C) were applied infusion of 10% intralipid until the end of surgery. The incidence of PONV, needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively.


Locations(1)

Erzurum, Turkey

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ACTRN12614000703606