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

Gwak 2007.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: South Korea
 Multisite: no
 International: no
 Treatment duration: intraoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): laparotomy, laparoscopic abdominal or gynaecological surgery
 Randomization unit: participants
 Analysis unit: individual
Participants

  1. 200 participants enrolled

  2. ASA I to II participants aged 20 to 60 years undergoing laparotomy or laparoscopic abdominal or gynaecologic surgery


Exclusion criteria included:

  1. history of PONV;

  2. smoking;

  3. alcohol use;

  4. narcotic use;

  5. antiemetic use;

  6. history of cardiovascular, hepatic, renal, gastrointestinal, and neurological diseases.


Randomized to:

  1. group 1 (n = 50, 25%);

  2. group 2 (n = 50, 25%);

  3. group 3 (n = 50, 25%);

  4. group 4 (n = 50, 25%).


Main characteristics of participants:

  1. age (mean, standard deviation): group 1 42.8 years, 11.1; group 2 43.0 years, 9.1; group 3 42.6 years, 9.6; group 4 41.3 years, 9.8;

  2. number of females/males: 187/13.
Interventions

  1. Group 1 (control): intraoperative infusion of 6 mL/kg/hour Ringer's lactate, ventilated with FiO2 0.3.

  2. Group 2 (intervention): intraoperative infusion of 18 mL/kg/hour Ringer's lactate, ventilated with FiO2 0.3.

  3. Group 3 (intervention): intraoperative infusion of 6 mL/kg/hour Ringer's lactate, ventilated with FiO2 0.8.

  4. Group 4 (control): intraoperative infusion of 18 mL/kg/hour Ringer's lactate, ventilated with FiO2 0.8.
Outcomes

  1. Nausea was assessed using a 10 cm visual analogue scale. These data were converted to categories (0 = none, 1 to 3 = mild, 4 to 6 = moderate, 7 to 10 = severe) and reported as such. Vomiting events were documented, as was postoperative antiemetic and analgesic administration.

  2. Pain was assessed using a 10 cm visual analogue scale and reported as means and standard deviations for each group.

  3. These outcomes were reported for each of the following time periods: 0 to 2 hours, 2 to 6 hours, and 6 to 24 hours postoperatively.

  4. The risk of nausea (all severities), vomiting, PONV, and rescue antiemetic and analgesic administration were reported for the overall postoperative period (0 to 24 hours).
Notes Groups with the same intraoperative fluid management but different inspired concentrations of oxygen were combined for meta‐analysis.
Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: stated on page S33
 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 conducted by computer‐generated codes that were maintained in sequentially numbered envelopes.
Allocation concealment (selection bias) Low risk Randomization was conducted by computer‐generated codes that were maintained in sequentially numbered envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk PACU nurses were blinded to the allocation group, but blinding of the anaesthesiologist caring for participants was not stated.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The postoperative study investigator was blinded to the group assignment.
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.