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. 2019 Mar 29;2019(3):CD012212. doi: 10.1002/14651858.CD012212.pub2

Murshed 2012.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: Bangladesh
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): elective laparoscopic surgery
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 90 participants enrolled

  2. ASA I to II participants aged 22 to 55 years undergoing elective laparoscopic surgery


Exclusion criteria included:
  1. history of significant PONV;

  2. motion sickness;

  3. pregnancy;

  4. lactation;

  5. operative time exceeding 2 hours;

  6. fasting greater than 12 hours.


Randomized to:
  1. group A (n = 30, 33.3%);

  2. group B (n = 30, 33.3%);

  3. group C (n = 30, 33.3%).


Main characteristics of participants:
  1. age (mean, standard deviation): group A 35.67 years, 11.18; group B 30.87 years, 6.66; group C 36.20 years, 12.30;

  2. number of females/males: not stated.

Interventions
  1. Group A (intervention): preoperative bolus of 15 mL/kg Ringer's lactate

  2. Group B (control): preoperative infusion of 1.5 mL/kg/hour Ringer's lactate "for the period of fasting"

  3. Group C (intervention): preoperative infusion of 1.5 mL/kg/hour Ringer's lactate "for the period of fasting" and metoclopramide 0.15 mg/kg IV before induction of anaesthesia


Co‐interventions: none stated
Outcomes
  1. Nausea, vomiting, and retching were assessed and reported as dichotomous outcomes using questionnaires. These outcomes were reported for the overall postoperative period as well as for the following time periods: 0 to 1, 1 to 6, and 6 to 24 hours postoperatively.

  2. Rescue antiemetic administration was recorded and reported.

  3. Total dose of postoperative tramadol was recorded and reported.

  4. Heart rate and mean arterial pressure were measured and reported in the preoperative, intraoperative, and postoperative periods.

Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: not stated
 Conducted: dates not stated
 Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The blind envelope method was used to randomize participants to groups.
Allocation concealment (selection bias) Unclear risk The blind envelope method was used to randomize participants to groups.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The participant, anaesthesia provider, and PACU nurses were blinded to group allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The study investigator was blinded to group allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals were stated.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk There were no other sources of bias.