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

Behdad 2011.

Methods Design: double‐blind, prospective randomized controlled trial
Country: Iran
Multisite: no
International: no
Treatment timing: intraoperative period
Follow‐up: 24 hours postoperatively
Operative procedure(s): tympanomastoidectomy
Randomization unit: participants
Analysis unit: individual
Participants
  1. 97 participants enrolled

  2. ASA I males and females, undergoing tympanomastoidectomy under general anaesthesia


Screened participants were excluded:
  1. if they had significant underlying disease (e.g. hypertension, cardiovascular disease, heart failure, epilepsy, diabetes, gastrointestinal disease, history of motion sickness, history of PONV, anti‐emetic use 24 hours preoperatively, smoking, drug allergy, or ASA greater than I);

  2. in the event of intraoperative hypotension (i.e. systolic blood pressure below 80 mmHg) and intraoperative haemorrhage.


Randomized to:
  1. group G4 (n = 30, 30.9%);

  2. group G10 (n = 33, 34.0%);

  3. group G20 (n = 34, 35.1%).


Main characteristics of participants:
  1. age (mean, standard deviation): G4 26.4, 9.5; G10 28.9, 11.2; G20 30.0, 11;

  2. number of females/males: 49/48.

Interventions
  1. G4 (control): infusion of 4 mL/kg Ringer's lactate

  2. G10 (intervention): infusion of 10 mL/kg Ringer's lactate

  3. G20 (intervention): infusion of 20 mL/kg Ringer's lactate


Co‐interventions: none stated
Outcomes
  1. Vomiting measured dichotomously

  2. Nausea was measured on an ordinal scale of "mild", "moderate", or "severe"

  3. Postoperative pain was evaluated by VAS (0 to 10 score range)

  4. Antiemetic administration in PACU was recorded

  5. Sore throat, thirst, and vertigo were also measured


These outcomes were all measured in the recovery room until discharge from the recovery room.
Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: stated
 Conducted: summer 2009
 Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Paper states participants were (quote) "randomly allocated" but does not explain further.
Allocation concealment (selection bias) Unclear risk Paper states participants were (quote) "randomly allocated" but does not explain further.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk It is stated that the study is (quote) "double‐blind", but it is not clear that the surgical care team was blinded to the intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Study personnel measuring outcomes were not aware of 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.