| Study characteristics |
| Methods |
Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis and combination prophylaxis |
| Participants |
Baseline characteristics
Granisetron
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) Weight (mean ± SD, median (IQR), median (range)): NA BMI (mean ± SD, median (IQR), median (range)): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): 0/0 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA ("All the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) Use of perioperative opioids (if yes, which?): none Type of surgery: breast surgery
Dexamethasone
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) Weight (mean ± SD, median (IQR), median (range)): NA BMI (mean ± SD, median (IQR), median (range)): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): 0/0 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) Use of perioperative opioids (if yes, which?): none Type of surgery: breast surgery
Granisetron + dexamethasone
Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): 30 Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) Weight (mean ± SD, median (IQR), median (range)): NA BMI (mean ± SD, median (IQR), median (range)): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): 0/0 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): NA ("all the 3 groups were statistically comparable as regards to age, BMI and duration of anaesthesia", no data provided) Use of perioperative opioids (if yes, which?): none Type of surgery: breast surgery
Included criteria: female, ASA I and II, 40 to 60 years of age, scheduled to undergo breast surgery
Excluded criteria: history of preoperative nausea and vomiting (24 hours before surgery), history of PONV after previous anaesthesia, taking antiemetics/opioids/hormonal therapy, disease prolonging gastric emptying like diabetes mellitus, intestinal obstruction, hiatus hernia, obese (BMI > 30), pregnant, history of motion sickness, known hypersensitivity to study drug
Pretreatment: baseline characteristics (ASA): no; (age, BMI): unclear. Potential effect modifiers (gender, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia, non‐smoker): unclear |
| Interventions |
Intervention characteristics
Granisetron
Dose: 3 mg Time point of administration: 5 minutes before induction Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 10 mg
Dexamethasone
Dose: 8 mg Time point of administration: 5 minutes before induction Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 10 mg
Granisetron + dexamethasone
Dose: granisetron 3 mg, dexamethasone 8 mg Time point of administration: 5 minutes before induction Route of administration: IV Rescue antiemetics (if yes, which?): metoclopramide 10 mg
|
| Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Extrapyramidal symptoms (0 to 24 hours)
Headache (0 to 24 hours)
Sedation/drowsiness (0 to 24 hours)
|
| Identification |
Sponsorship source: NA
Country: India
Setting: inpatient, single‐centre
Author's name: Kanwalpreet Sodhi
Institution: Department of Anaesthesia, MMM, Chennai, India
Email: NA
Address: 4‐A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai, Tamil Nadu 600037, India
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: NA |
| Notes |
None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "further divided randomly into three groups of 30 patients each"
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 |
Unclear risk |
Quote: "double‐blind"
Judgement comment: insufficient information on blinding |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Judgement comment: insufficient information on blinding ("double‐blind") |
| 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: "all the three groups were statistically comparable as regards to age, BMI and duration of anaesthesia and also the postoperative vitals"
Judgement comment: baseline characteristics (ASA): no; (age, BMI): unclear. Potential effect modifiers (gender, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia, non‐smoker): unclear |
