| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis and combination prophylaxis |
| Participants |
Baseline characteristics
Placebo
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 67 ± 9.3 Weight (mean ± SD, median (IQR), median (range)): NA BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 52 Non‐smoker (%): 88 History of PONV/motion sickness (%): 0 Type of general anaesthesia: TIVA (propofol), N₂O Duration of anaesthesia or surgery (in min; as mean or median): 36.2 Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl at induction Type of surgery: cataract surgery
Metoclopramide
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 61.5 ± 10.1 Weight (mean ± SD, median (IQR), median (range)): NA BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 40 Non‐smoker (%): 80 History of PONV/motion sickness (%): 0 Type of general anaesthesia: TIVA (propofol), N₂O Duration of anaesthesia or surgery (in min; as mean or median): 38.5 Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl at induction Type of surgery: cataract surgery
Dexamethasone
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 65.9 ± 11.4 Weight (mean ± SD, median (IQR), median (range)): NA BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 44 Non‐smoker (%): 88 History of PONV/motion sickness (%): 0 Type of general anaesthesia: TIVA (propofol), N₂O Duration of anaesthesia or surgery (in min; as mean or median): 35.4 Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl at induction Type of surgery: cataract surgery
Metoclopramide + dexamethasone
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 25 Received treatment (n): NA Analysed (n): 25 Age (mean ± SD, median (IQR), median (range)): 71 ± 5.9 Weight (mean ± SD, median (IQR), median (range)): NA BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 56 Non‐smoker (%): 88 History of PONV/motion sickness (%): 0 Type of general anaesthesia: TIVA (propofol), N₂O Duration of anaesthesia or surgery (in min; as mean or median): 37.2 Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl at induction Type of surgery: cataract surgery
Included criteria: cataract surgery under general anaesthesia, ASA I or II
Excluded criteria: diabetes mellitus or other underlying disorders, use of antiemetics during past 24 hours, positive history of motion sickness or PONV
Pretreatment: baseline characteristics (age, ASA): no; (weight): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |
| Interventions |
Intervention characteristics
Placebo
Dose: saline Time point of administration: 1 minute before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Metoclopramide
Dose: 10 mg Time point of administration: 1 minute before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Dexamethasone
Dose: 8 mg Time point of administration: 1 minute before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
Metoclopramide + dexamethasone
Dose: metoclopramide 10 mg, dexamethasone 8 mg Time point of administration: 1 minute before induction of anaesthesia Route of administration: IV Rescue antiemetics (if yes, which?): NA
|
| Outcomes |
Vomiting (0 to 24 hours)
Vomiting (recovery room)
Nausea (0 to 24 hours)
|
| Identification |
Sponsorship source: NA
Country: Iran
Setting: inpatient, single‐centre
Author's name: M. Khoshbaten
Institution: Drug Applied Research Centre, Tabriz, Islamic Republic of Iran
Email: mkhoshbaten@yahoo.com
Address: NA
Duration of study: NA
Language: English
Study's primary outcome: PONV
Trial registry number: NA |
| Notes |
None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "the patients were randomly assigned by block randomization to one of 4 groups of 25 patients: placebo..."
Judgement comment: no further information on sequence generation provided |
| Allocation concealment (selection bias) |
Unclear risk |
Judgement comment: no statement |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "...kg) and atracurium (0.5 mg/kg). They were given by the anaesthetist who was unaware of the drug allocation" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "...of those needing treatment for PONV were evaluated by nurses, who were blind to the patient’s group as the drug administered was not recorded on the patient’s anaesthesia chart. The occurrence of PONV was also recorded 24 hours following..." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Judgement comment: no missing outcome data |
| Selective reporting (reporting bias) |
Unclear risk |
Judgement comment: no reference to a study protocol or trial registry number reported |
| Other bias |
Unclear risk |
Quote: "in the final analysis. There were no significant differences between the background characteristics of patients in the 4 groups in terms of age, sex, duration of surgery or history of smoking (Table 1)"
Judgement comment: baseline characteristics (age, ASA): no; (weight): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |
