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

Maharaj 2005.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: Ireland
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 72 hours postoperatively
 Operative procedure(s): diagnostic gynaecological laparoscopy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 80 participants enrolled

  2. ASA I to III female participants aged 18 to 50 years undergoing diagnostic gynaecologic laparoscopy


Exclusion criteria included:
  1. history of relevant drug allergy;

  2. cigarette smoking;

  3. surgical procedure beyond diagnostic laparoscopy.


Excluded after randomization:
  1. intraoperative hypotension;

  2. excessive blood loss;

  3. if the surgery progressed to include additional procedures.


Randomized to:
  1. control group (n = 39, 48.8%);

  2. large‐volume infusion group (n = 41, 51.2%);

  3. no withdrawals were reported.


Main characteristics of participants:
  1. age (mean, standard error of mean): control group 35.8 years, 1.4; large volume infusion group 33.7 years, 1.4;

  2. number of females/males: 80/0.

Interventions
  1. Control group (control): preoperative bolus of 2 mL/kg Ringer's lactate for each hour fasted preoperatively

  2. Large‐volume infusion group (intervention): preoperative bolus of 3 mL/kg Ringer's lactate


Co‐interventions: none stated
Outcomes
  1. Nausea was assessed using a 10‐point verbal analogue scale at 5 time points: in PACU when conversant, and at 1, 4, 24, and 72 hours postoperatively. Nausea severity was scored as none (0), mild (1 to 2), moderate (3 to 5), or severe (6 to 10). Vomiting events and administration of rescue antiemetics were documented.

  2. PONV events were reported as any occurrence of nausea (verbal analogue scale 1 to 10), vomiting, or need for antiemetic therapy.

  3. The number of participants who required overnight admission to hospital was reported.

  4. Pain was also assessed at each time point using a 10‐point verbal analogue scale. Administration of analgesic medication was also documented.

Notes Trial registration: not stated
 Funder: "funded from departmental resources"
 A priori sample size estimation: stated on page 676
 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 Sealed envelopes were used to determine group allocation.
Allocation concealment (selection bias) Unclear risk Sealed envelopes were used to determine group allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants, anaesthesiologists, and PACU nurses were blind to group allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The investigator completing patient assessments in PACU was blind to group allocation.
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.