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

Cook 1990.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: England
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 3 days postoperatively
 Operative procedure(s): ambulatory laparoscopy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 75 participants enrolled

  2. ASA I to II females aged 18 to 40 years undergoing ambulatory diagnostic laparoscopy


Exclusion criteria included:
  1. use of any routine medication.


Randomized to:
  1. control group (n = 24, 32.9%);

  2. RL group (n = 24, 32.9%);

  3. RL/dextrose group (n = 25, 34.2%).


Two participants were apparently randomized but not included in the results. No reason for exclusion was given.
Main characteristics of participants:
  1. age (mean, standard deviation): control group 31.5 years, 6.2; RL group 31.4 years, 6.5; RL/dextrose group 32.9 years, 6.5;

  2. number of females/males: 73/0.

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

  2. RL group (intervention): preoperative bolus of 20 mL/kg Ringer's lactate

  3. RL/dextrose group (intervention): preoperative bolus of 20 mL/kg Ringer's lactate with 1 g/kg dextrose


Co‐interventions: none stated
Outcomes
  1. Risk of nausea and vomiting assessed as a dichotomous outcome on a questionnaire completed by the participant before the operation, at 3 hours postoperatively, and then on postoperative days 1, 2, and 3.

  2. The questionnaire also included questions about the risk of pain, hunger, dizziness, thirst, drowsiness, headache, sore throat, abdominal pain, and faintness on standing.

  3. Administration of antiemetic and analgesic medications in the postoperative period were recorded and reported.

  4. Eye opening on command was tested at 1‐minute intervals postoperatively and the ability to give date of birth correctly postoperatively was documented.

  5. A Trieger test was performed, test recovery from the anaesthetic, at 15, 60, 120, and 180 minutes postoperatively.

  6. Readiness for discharge using criteria of steady gait and general well‐being was assessed. Both the observer and the participant graded readiness for discharge as: ready immediately, delayed until fit, or to be admitted overnight.

  7. Preoperative and 3‐hour postoperative blood glucose levels were reported.

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) Unclear risk Paper states (quote) "each patient was allocated at random" but no further information on methodology provided.
Allocation concealment (selection bias) Unclear risk Paper states (quote) "each patient was allocated at random" but no further information on methodology provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Infusion bags were hidden to prevent unblinding, but it was not specified how this applied to the (quote) "no preoperative fluid" group.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessments were made by an author blinded to treatment groups.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Two patients were not assessed. Material impact questionable as this represents a small fraction of the participants but no explanation was given.
Selective reporting (reporting bias) Unclear risk All outcomes were reported. An intention‐to‐treat analysis was not completed.
Other bias Low risk There were no other sources of bias.