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

Ali 2003.

Methods Design: double‐blind, prospective randomized controlled trial
Country: USA
Multisite: no
International: no
Treatment timing: preoperative period
Follow‐up: 24 hours postoperatively
Operative procedure(s): laparoscopic or gynaecological surgery
Randomization unit: participants
Analysis unit: individual
Participants
  1. 80 participants enrolled

  2. ASA I to II males and females aged 18 to 70 years undergoing laparoscopic or gynaecological surgery lasting at least 1 hour


Screened participants were excluded if they:
  1. experienced nausea or vomiting on the morning of surgery;

  2. were taking antiemetic drugs;

  3. had a documented disorder of the cardiovascular, hepatic, renal, gastrointestinal, or neurological systems.


Randomized to:
  1. supplemental fluid (n = 40, 50%);

  2. conservative fluid (n = 40, 50%).


No withdrawals were stated.
Main characteristics of participants:
  1. age (mean, com deviation): supplemental group 39 years, 10; conservative group 41 years, 11;

  2. number of females/males: 70/4 (6 not stated).

Interventions
  1. Supplemental fluid group (intervention): preoperative bolus of 15 mL/kg Ringer's lactate

  2. Conservative fluid group (control): preoperative bolus of 2 mL/kg Ringer's lactate


Co‐interventions: none stated
Outcomes Primary outcomes:
  1. Nausea was assessed by 100 mm visual analogue scale at 15‐minute intervals throughout PACU recovery (1 hour). A score of 50 mm or greater was considered significant. Episodes of vomiting and the need for rescue antiemetics in PACU were noted. Patients were called the following day and nausea (100 mm visual analogue scale) and vomiting (episodes) in the post‐discharge period were documented.


Outcomes were reported in the following time periods: 0 to 1 hour, 1 to 24 hours, and 0 to 24 hours postoperatively
Secondary outcomes included:
  1. admission to hospital after discharge.

Notes Trial registration: not found
 Funder: none stated
 A priori sample size estimation: stated on page 782
 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 Randomization was based on computer‐generated codes that were maintained in sequentially numbered, opaque envelopes.
Allocation concealment (selection bias) Unclear risk Randomization was based on computer‐generated codes that were maintained in sequentially numbered, opaque envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The anaesthesia provider, the postoperative study investigator, and the PACU nurses were blinded to allocation of the groups, as were the participants.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The anaesthesia provider, the postoperative study investigator and the PACU nurses were blinded to allocation of the groups, as were the participants.
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.