| RCT Data Extraction | Notes | ||||||||
| Identification | |||||||||
| Study details: | |||||||||
| First author | |||||||||
| Year of publication | |||||||||
| Journal | |||||||||
| Country (location of study conduct) | |||||||||
| Number of centres | |||||||||
| Duration of study (date) | |||||||||
| Trial registry number | |||||||||
| Author’s contact details (corresponding author): | |||||||||
| Author’s name | |||||||||
| e‐mail address | |||||||||
| Methods | |||||||||
| Study design | |||||||||
| Groups | |||||||||
| Population | |||||||||
| Inclusion criteria | |||||||||
| Exclusion criteria | |||||||||
| Significant group differences (baseline imbalance)? (Y/N) | |||||||||
| Participant flow: | |||||||||
| # assessed for eligibility (n) | |||||||||
| # enrolled (n) | |||||||||
| # randomized (n/n) | |||||||||
| # received treatment (n/n) | |||||||||
| # analysed (n/n) | |||||||||
| Potential effect modifiers | |||||||||
| Population and baseline characteristics: | |||||||||
| Gender | |||||||||
| Non‐smoker | |||||||||
| History of PONV/motion sickness | |||||||||
| Type of general anaesthesia | |||||||||
| Duration of anaesthesia | |||||||||
| Use of perioperative opioids (if yes, which?) | |||||||||
| Type of surgery | |||||||||
| Significant imbalance between groups? (Y/N) If yes, please define. | |||||||||
| Intervention | |||||||||
| Dose | |||||||||
| Time point of administration | |||||||||
| Route of administration | |||||||||
| Risk of bias (see Appendix 4: critical appraisal form) | |||||||||
| Allocation concealment | |||||||||
| Blinding of participant and personnel | |||||||||
| Blinding of outcome assessors | |||||||||
| Incomplete outcome data | |||||||||
| Funding source | |||||||||
| Sponsorship source | |||||||||
| Sponsorship involvement | |||||||||
| Outcome data | |||||||||
| Type of outcome | Definition of outcome | Observation time period | Intervention (events) | Intervention (n) |
Control (events) |
Control (n) | |||
| Vomiting (0 to 24 hours) | |||||||||
| Vomiting (0 to six hours) | |||||||||
| Vomiting (two to 24 hours) | |||||||||
| Nausea | |||||||||
| Subjects with any SAE | |||||||||
| Subjects with any AE | |||||||||
| Mortality | |||||||||
| Arrhythmia | |||||||||
| QT prolongation | |||||||||
| Extrapyramidal symptoms | |||||||||
| Postoperative wound infection | |||||||||
| Headache | |||||||||
| Constipation | |||||||||
| Sedation/drowsiness | |||||||||
| Visual disturbances (e.g. blurred vision) | |||||||||
| Monitoring and reporting of (severe) adverse events: | |||||||||
| Yes | No | Unclear | Risk of Bias | Note | |||||
| Did the authors actively monitor for AEs (any AE)? | |||||||||
| Did the authors simply provide spontaneous reporting of AEs that arose? | |||||||||
| Did the authors only actively monitor for defined AEs and other relevant AEs were not monitored? | |||||||||
| Did the authors define SAEs according to an accepted international classification and report the number of SAEs? | |||||||||