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

Onyando 2014.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: Kenya
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): gynaecological surgery
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 60 participants enrolled

  2. ASA I to II female participants aged 18 to 65 years undergoing elective gynaecologic surgery


Exclusion criteria included:
  1. a history of smoking;

  2. PONV or motion sickness, or both;

  3. hypertension;

  4. diabetes;

  5. heart disease;

  6. epilepsy;

  7. mental disability;

  8. participants undergoing emergency procedures;

  9. having regional anaesthesia were excluded;

  10. pregnancy;

  11. prisoners;

  12. participants who experienced intraoperative hypotension or significant blood loss (requiring transfusion);

  13. those given an enema for bowel prep before surgery.


Randomized to:
  1. group 1 (n = 30, 50%);

  2. group 2 (n = 30, 50%).


Main characteristics of participants:
  1. age (mean, standard deviation): group 1 39 years, 11.34; group 2 39.03 years, 11.33;

  2. number of females/males: 60/0.

Interventions
  1. Group 1 (control): no preoperative bolus

  2. Group 2 (intervention): preoperative bolus of Ringer's lactate in an amount equal to the hours fasting multiplied by the patient's maintenance fluid requirement per hour up to 1000 mL


Co‐interventions: none stated
Outcomes
  1. Nausea was assessed using a 10‐point visual analogue scale, but only if a participant volunteered symptoms of nausea to a nurse. It was reported as a dichotomous outcome for the PACU stay, at 12 hours, and at 24 hours.

  2. Vomiting was recorded and reported at the same time points.

  3. Antiemetic administration was reported for the entire 24‐hour postoperative period.

  4. Systolic blood pressure, diastolic blood pressure, and heart rate were recorded and reported at the following times: pre‐induction and at 5, 15, 30, 45, 60, 75, and 90 minutes post‐intubation.

Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: stated on page 13
 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 table of random numbers.
Allocation concealment (selection bias) Unclear risk Randomization was completed using a computer‐generated table of random numbers.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Study participants, the anaesthetist, PACU nurses, and post‐surgical ward nurses were unaware of the group assignments.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Postoperative care nurses documented outcomes and were blinded to group allocation.
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 Unclear risk The duration of anaesthesia was significantly shorter for the experimental group.