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

Lee 2009.

Methods Design: blinded, prospective randomized controlled trial
 Country: South Korea
 Multisite: no
 International: no
 Treatment duration: preoperative/intraoperative 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 participants aged 19 to 60 years undergoing laparoscopic cholecystectomy


Exclusion criteria included:
  1. history of cardiopulmonary disease;

  2. endocrine disorders;

  3. ringworm;

  4. obesity;

  5. kidney disease;

  6. PONV;

  7. motion sickness;

  8. fever;

  9. conversion from laparoscopic to open procedure.


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

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

  3. group III (n = 30, 33.3%).


Main characteristics of participants:
  1. age (mean, standard deviation): group I 50.5 years, 10.5; group II 51.1 years, 8.1; group III 49.2 years, 8.5;

  2. number of females/males: 53/37.

Interventions
  1. Group I (control): preoperative infusion of 5 mL/kg/hour Ringer's lactate

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

  3. Group III (intervention): preoperative infusion of 5 mL/kg/hour Ringer's lactate and intraoperative administration of ondansetron 4 mg IV


Co‐interventions: none stated
Outcomes
  1. Nausea and vomiting were documented as dichotomous outcomes. These were reported as a composite outcome for the following time points: 0 to 1, 1 to 12, and 12 to 24 hours postoperatively. An risk for the overall 24 hour period was also reported.

  2. Antiemetic administration was documented.

  3. Pain was measured by visual analogue scale.

  4. Nausea, vomiting episodes, and antiemetic administration were also recorded. Pain was assessed using a visual analogue scale at 1, 12, and 24 hours.

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 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 Blinding of participants and the perioperative team was not discussed.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The outcome assessor was 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 Low risk There were no other sources of bias.