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

Magner 2004.

Methods Design: double‐blind, prospective, randomized controlled trial.
 Country: UK
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 48 hours postoperatively
 Operative procedure(s): gynaecological laparoscopy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 141 participants enrolled

  2. ASA I female participants aged 21 to 44 years undergoing elective gynaecologic laparoscopy for investigation of infertility


Exclusion criteria included:
  1. history of congestive heart failure;

  2. hypertension;

  3. valvular heart disease;

  4. diabetes mellitus;

  5. epilepsy;

  6. relevant drug allergy;

  7. established gastrointestinal disease;

  8. received antiemetic medication in the 24 hours before surgery;

  9. development of intraoperative hypotension;

  10. excessive blood loss;

  11. surgery involved more than diagnostic laparoscopy.


Randomized to:
  1. RL‐10 group (n = 71, 50.4%);

  2. RL‐30 group (n = 70, 49.6%);

  3. 1 participant was excluded for protocol violation.


Main characteristics of participants:
  1. age (mean, range): RL‐10 33.5 years, 21 to 42; RL‐30 33.0 years, 21 to 44;

  2. number of females/males: 141/0.

Interventions
  1. RL‐10 group (control): preoperative bolus of 10 mL/kg Ringer's lactate

  2. RL‐30 group (intervention): preoperative bolus of 30 mL/kg Ringer's lactate


Co‐interventions: none stated.
Outcomes
  1. Nausea and vomiting/dry retching were assessed using a standardized questionnaire performed 30 minutes after emergence from anaesthesia and at 2, 24, and 48 hours postoperatively.

  2. Nausea was assessed using an ordinal scale (severe/moderate/mild/none).

  3. Nausea was reported as several dichotomous outcomes: severe nausea or not, severe with antiemetic provided or not, or presence of any severity of nausea or not.

  4. Antiemetic use was also documented and reported at the same time points.

  5. On the same questionnaire, participants were also queried on the presence or absence of sore throat, dizziness, and thirst.

  6. Administration of simple and opiate analgesia was also documented.

Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: stated on page 382
 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 completed using a computer‐generated random number sequence.
Allocation concealment (selection bias) Unclear risk Randomization was completed using a computer‐generated random number sequence.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Fluid was administered in the preoperative area; the participant and perioperative team were not aware of group allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessment was completed by a blind investigator.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals were noted.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk There were no other sources of bias.