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

Hashish 2007.

Methods Design: prospective randomized controlled trial
 Country: Egypt
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): diagnostic gynaecological laparoscopy for infertility
 Randomization unit: participants
 Analysis unit: individual
Participants

  1. 60 participants enrolled

  2. ASA I to II females aged 18 to 40 years weighing 50 kg to 85 kg undergoing diagnostic gynaecological laparoscopy for infertility


Exclusion criteria included:

  1. gastrointestinal disease;

  2. diabetes mellitus;

  3. epilepsy;

  4. antiemetic use within 24 hours before the operation;

  5. excessive intraoperative blood loss;

  6. additional intraoperative surgical intervention.


Randomized to:

  1. group I (n = 20, 33.3%);

  2. group II (n = 20, 33.3%);

  3. group III (n = 20, 33.3%).


Main characteristics of participants:

  1. age (mean, range): group I 25.2 years, 19 to 33; group II 24.5 years, 18 to 30, group III 25.5 years, 20 to 35;

  2. number of females/males: 60/0.
Interventions

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

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

  3. Group III (intervention): preoperative bolus of 10 mL/kg and administration of ephedrine 0.5 mg/kg intramuscularly 10 minutes before the end of surgery


Co‐interventions: none stated

  1. Preoperative bolus of 30 mL/kg or 10 mL/kg Ringer's lactate. A third group received 10 mL/kg Ringer's lactate preoperatively and 0.5 mg/kg ephedrine IM intraoperatively.
Outcomes

  1. Vomiting and dry retching (assessed and reported as a single outcome) and nausea were assessed as dichotomous outcomes using a patient questionnaire. These outcomes were reported at 30 minutes, 2.5 hours, and 2.5 to 24 hours postoperatively.

  2. Other outcomes included headache, sedation, sore throat, thirst, and shoulder pain. These were reported for the overall postoperative period.

  3. Perioperative vital signs (heart rate, mean arterial pressure, and arterial O2 saturation) were also reported at the following time points: baseline; 5, 20, and 40 minutes after intubation; 30 minutes, 2.5 hours, and 24 hours postoperatively.
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 No information on blinding of participants and personnel provided.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information on blinding of outcome assessment provided.
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.