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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000703606
Enrollment
120
Registered
2014-07-03
Start date
2014-01-01
Completion date
2014-06-10
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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. 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

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.

Sponsors

Ataturk University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

18- 65 years female and male ASA I-II patients undergoing laparoscopic cholecystectomy

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026