Skip to main content
. 2019 Mar 29;2019(3):CD012212. doi: 10.1002/14651858.CD012212.pub2

Ismail 2017.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: Egypt
 Multisite: no
 International: no
 Treatment duration: intraoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): laparoscopic cholecystectomy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 100 participants enrolled

  2. ASA I to II participants aged 20 to 50 years undergoing laparoscopic cholecystectomy


Exclusion criteria included:
  1. use of steroids, antiemetics, or opioids in the 3 days prior to surgery;

  2. liver, cardiac, or renal disease;

  3. pregnancy;

  4. body mass index > 30 kg/m2.


Randomized to:
  1. group D (n = 50, 50%);

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

  3. all randomized participants completed the study.


Main characteristics of participants:
  1. age (mean, standard deviation): group D 34.6 years, 5.60; group DF 33.4 years, 4.96;

  2. number of females/males: 100/0.

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

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


Co‐interventions: both groups received dexamethasone 5 mg IV at the beginning of surgery
Outcomes
  1. PONV was measured using a verbal descriptive scale: none, mild, moderate, or severe.

  2. Nausea, retching, and vomiting were presented as individual overall dichotomous outcomes, as well as at early (0 to 6 hour) and late (6 to 24 hour) time points.

  3. Antiemetic administration was presented as a dichotomous outcome and as total dose administered.

  4. Pain was reported on a visual analogue scale.

  5. Time to first analgesia request and total meperidine requirement were reported.

  6. Delayed complications, specifically wound infection, delayed wound healing, and inflammation or wound discharge were reported.

  7. Time required to achieve an Aldrete score of 10 was recorded.

Notes Trial registration: NCT02726308Funder: not stated
 A priori sample size estimation: stated
 Conducted: May 2015 to December 2015
 Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was based on computer‐generated codes maintained in sequentially numbered, opaque envelopes.
Allocation concealment (selection bias) Low risk Randomization was based on computer‐generated codes maintained in sequentially numbered, opaque envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants and members of the surgical team were blind to group allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Nurses collecting data in PACU were blind 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.