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

Monti 1999.

Methods Design: prospective randomized controlled trial
 Country: USA
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: until discharge from the ambulatory care unit
 Operative procedure(s): gynaecological laparoscopy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 90 participants enrolled

  2. ASA I to II female participants aged 18 to 55 years undergoing non‐emergency ambulatory gynaecological laparoscopy


Exclusion criteria included:
  1. pregnancy;

  2. history of nausea or vomiting.


Randomized to:
  1. control group (n = 45, 50%);

  2. experimental group (n = 45, 50%);

  3. it was unclear from the information presented whether there were any withdrawals.


Main characteristics of participants:
  1. information on the mean age of each group was not provided; it was stated that there was no difference in the mean age;

  2. number of females/males: 90/0.

Interventions
  1. Control group (control): "the usual" amount of Ringer's lactate as dictated by the attending anaesthetist

  2. Experimental fluid group (intervention): preoperative bolus of 1 litre of Ringer's lactate


Co‐interventions: none stated
Outcomes
  1. The risk of nausea and vomiting were evaluated and reported as dichotomous outcomes.

  2. Overall risk for the duration participant's postanaesthetic care unit and ambulatory surgical unit stay (until time of discharge) was reported.

  3. Rescue antiemetic administration was also reported for the overall postoperative period.

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 Participants were randomly assigned using a random distribution table.
Allocation concealment (selection bias) Unclear risk Participants were randomly assigned using a random distribution table.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding of participants and personnel was not described.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Blinding of outcome assessors was not described.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The number of withdrawals was not stated and denominators were not provided for any reported results.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk There were no other sources of bias.