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

Chauhan 2013.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: India
 Multisite: no
 International: no
 Treatment duration: perioperative period
 Follow‐up: 4 hours postoperatively
 Operative procedure(s): elective gynaecological laparoscopy
 Randomization unit: participants
 Analysis unit: individual
Participants

  1. 200 participants enrolled

  2. Female ASA I to II participants aged 20 to 40 years undergoing ambulatory, elective gynaecological laparoscopic surgery in the supine position under general anaesthesia with controlled ventilation


Exclusion criteria included:

  1. a history of hypertension;

  2. diabetes;

  3. congestive cardiac failure;

  4. valvular heart disease;

  5. motion sickness;

  6. epilepsy;

  7. haemoglobin level less than [10 g%];

  8. relevant drug allergy;

  9. undergoing a procedure in addition to diagnostic laparoscopy;

  10. administration of antiemetic medication in the 24 hours before surgery;

  11. intraoperative hypotension;

  12. excessive blood loss.


Randomized to:

  1. group I (n = 100, 50%);

  2. group II (n = 100, 50%);

  3. no withdrawals were stated.


Main characteristics of participants:

  1. age (mean, standard deviation): group I 28.73 years, 4.65; group II 28.73 years, 4.98;

  2. number of females/males: 200/0.
Interventions

  1. Group I (control): preoperative bolus of 10 mL/kg Ringer's lactate

  2. Group II (intervention): preoperative bolus of 30 mL/kg Ringer's lactate


Co‐interventions: none stated
Outcomes

  1. Nausea and vomiting were assessed every 30 minutes from the time the participant regained full consciousness until 4 hours postoperatively.

  2. Episodes of retching and vomiting were documented.

  3. PONV was graded using the following scale: 0 = no nausea, 1 = nausea only, 2 = retching/1 episode of vomiting, 3 = > 1 episode of vomiting.

  4. The phase of menstrual cycle on the day of surgery (proliferative, secretory, or menstrual) was also documented.

  5. Systolic and diastolic blood pressure measurements were recorded and reported for time points corresponding to the preoperative period, intubation, surgical start time, mid‐procedure, end of surgery, extubation, and postoperative period.

  6. Rescue antiemetic administration was documented. Rescue antiemetics were administered for grade 2 or 3 PONV.
Notes Trial registration: not found
 Funder: "Pubmed articles, National Medical Library (AIIMS)" listed as 'source of support'
 A priori sample size estimation: not stated
 Conducted: dates not stated
 Declared conflicts of interest: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was performed using sealed envelopes.
Allocation concealment (selection bias) Unclear risk Randomization was performed using sealed envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Intervention IV fluid is not administered by a member of the care team.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The text states that (quote) "the investigator" administers the fluid preoperatively and interviews the patient postoperatively, but the paper states the investigator was blind to the patient's 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 Low risk There were no other sources of bias.