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

Heidari 2012.

Methods Design: prospective randomized controlled trial
 Country: Iran
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: unclear, "in the recovery room and surgical ward"
 Operative procedure(s): elective orthopaedic procedures
 Randomization unit: participants
 Analysis unit: individual
Participants

  1. 30 participants enrolled

  2. ASA I to II non‐smoking adults undergoing elective orthopaedic procedures involving the limbs


Exclusion criteria included:

  1. a history of motion sickness;

  2. those who required tourniquet placement during the operative procedure.


Randomized to:

  1. case group (n = 15, 50%);

  2. control group (n = 15, 50%);

  3. no withdrawals were stated.


Main characteristics of participants:

  1. age (mean, standard deviation): case group 24 years, 14; control group 25 years, 15;

  2. number of females/males: 0/30.
Interventions

  1. Case group (intervention): preoperative bolus of 10 mL/kg Ringer's lactate

  2. Control group (control): no preoperative fluid


Co‐interventions: none stated
Outcomes

  1. Nausea was assessed using a 10‐point visual analogue scale.

  2. The number of vomiting episodes and the administration of rescue antiemetic medication was documented.

  3. Nausea and vomiting were reported as a composite outcome. No threshold VAS score to define nausea was stated.

  4. Intraoperative heart rate and systolic, mean, and diastolic blood pressure were recorded.

  5. Baseline haemodynamic statistics were reported.
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) Low risk Random allocation software was used to produce a simple randomized list of 2 equal groups.
Allocation concealment (selection bias) Unclear risk Random allocation software was used to produce a simple randomized list of 2 equal groups.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Blinding not stated. Fluid intervention occurs when participant is awake with no stated sham treatment.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding status of outcome assessor not stated.
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.