Skip to main content
. 2019 Mar 29;2019(3):CD012212. doi: 10.1002/14651858.CD012212.pub2

McCaul 2003.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: UK
 Multisite: no
 International: no
 Treatment duration: intraoperative period
 Follow‐up: morning of the first postoperative day
 Operative procedure(s): elective gynaecological laparoscopy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 120 participants enrolled

  2. Female participants undergoing elective diagnostic laparoscopy


Participants were excluded after randomization:
  1. if they developed excessive blood loss;

  2. if the surgery progressed to include additional procedures.


Randomized to:
  1. control group (n = 37, 34.3%);

  2. RL group (n = 36, 33.3%);

  3. RL/dextrose group (n = 35, 32.4%);

  4. 12 participants were excluded after randomization from the 120 originally randomized. Their group allocation is not stated.


Main characteristics of participants:
  1. age (mean, standard deviation): control group 33.0 years, 5.1; RL group 32.3 years, 4.96; RL/dextrose group 33.2 years, 4.9;

  2. Number of females/males: 108/0.

Interventions
  1. Control group (control): no intraoperative fluid bolus

  2. RL group (intervention): intraoperative bolus of 1.5 mL/kg Ringer's lactate for each hour fasted preoperatively

  3. RL/dextrose group (intervention): intraoperative bolus of 1.5 mL/kg Ringer's lactate with dextrose 0.5 g/kg


Co‐interventions: none stated
Outcomes
  1. Nausea, vomiting, and antiemetic use were documented and reported as dichotomous outcomes. They were assessed using a standardized questionnaire in the PACU, at postoperative hour 2, and on the morning of the first postoperative day.

  2. The risk of thirst, dizziness, and sore throat were also documented and reported.

Notes Trial registration: not found
 Funder: none stated
 A priori sample size estimation: stated on page 441
 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 Unmarked envelopes were used to determine group allocation.
Allocation concealment (selection bias) Unclear risk Unmarked envelopes were used to determine group allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants were anaesthetized at the time of fluid administration. Blinding of personnel, including the attending anaesthesiologist, was not explained.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Participants were assessed by a blinded interviewer using a standardized questionnaire in the PACU.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 12 participants were excluded after randomization. No explanation was given for their exclusion. The groups to which each excluded patient was assigned was not identified.
Selective reporting (reporting bias) High risk An intention‐to‐treat analysis was not completed.
Other bias Low risk There were no other sources of bias.