McCaul 2003.
Methods | Design: double‐blind, prospective randomized controlled trial Country: UK Multisite: no International: no Treatment duration: intraoperative period Follow‐up: morning of the first postoperative day Operative procedure(s): elective gynaecological laparoscopy Randomization unit: participants Analysis unit: individual | |
Participants |
Participants were excluded after randomization:
Randomized to:
Main characteristics of participants:
|
|
Interventions |
Co‐interventions: none stated |
|
Outcomes |
|
|
Notes | Trial registration: not found Funder: none stated A priori sample size estimation: stated on page 441 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 | Unmarked envelopes were used to determine group allocation. |
Allocation concealment (selection bias) | Unclear risk | Unmarked envelopes were used to determine group allocation. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were anaesthetized at the time of fluid administration. Blinding of personnel, including the attending anaesthesiologist, was not explained. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants were assessed by a blinded interviewer using a standardized questionnaire in the PACU. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 12 participants were excluded after randomization. No explanation was given for their exclusion. The groups to which each excluded patient was assigned was not identified. |
Selective reporting (reporting bias) | High risk | An intention‐to‐treat analysis was not completed. |
Other bias | Low risk | There were no other sources of bias. |