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

Sharma 2010.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: India
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): laparoscopic cholecystectomy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 90 participants enrolled

  2. ASA I to II female participants aged 18 to 60 years undergoing elective laparoscopic cholecystectomy


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

  2. diabetes mellitus;

  3. epilepsy;

  4. valvular heart disease;

  5. hypertension;

  6. smoking;

  7. relevant drug allergy;

  8. established gastrointestinal disease;

  9. use of antiemetic medications in the 24 hours before surgery;

  10. developing intraoperative hypotension;

  11. developing excessive blood loss;

  12. those whose surgeries lasted longer than 2 hours.


Randomized to:
  1. group A (n = 30, 33.3%);

  2. group B (n = 30, 33.3%);

  3. group C (n = 30, 33.3%);

  4. no withdrawals were stated.


Main characteristics of participants:
  1. age (mean, standard deviation): group A 37.23 years, 11.43; group B 38.43 years, 12.33; group C 35.70, 10.06;

  2. number of females/males: 90/0.

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

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

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


Co‐interventions: none stated
Outcomes
  1. Nausea was assessed by 100 mm VAS at 0, 1, 4, 8, 12, 18, and 24 hours postoperatively. A score of greater than 50 mm was considered significant nausea.

  2. Episodes of vomiting and the administration of rescue antiemetics in PACU were recorded.

  3. The risk of sore throat, dizziness, and thirst was recorded for each participant.

Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: not stated; post hoc calculation provided on page 385
 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 Participants were randomly allocated, but no information on the randomization process was provided.
Allocation concealment (selection bias) Unclear risk Participants were randomly allocated, but no information on the randomization process was provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk The study is described as being "blind" but the blinding status of the perioperative personnel was not described.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The study is described as being "blind" but the blinding status of the outcome assessor was not described.
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.