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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Diemunsch 1997.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 5 groups, monoprophylaxis, dose‐finding study
Participants Baseline characteristics
Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 54

  • Received treatment (n): NA

  • Analysed (n): 54

  • Age (mean ± SD, median (IQR), median (range)): 34.7 ± 8.4

  • Weight (mean ± SD, median (IQR), median (range)): 59.2 ± 9.8

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 53/1/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 35.8/NA

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA

  • Use of perioperative opioids (if yes, which?): 300.5 µg fentanyl, 7.73 mg postoperative morphine

  • Type of surgery: laparoscopy or other gynaecological surgery (laparotomy or vaginal hysterectomy)


Dolasetron (12.5 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 54

  • Received treatment (n): NA

  • Analysed (n): 54

  • Age (mean ± SD, median (IQR), median (range)): 37.1 ± 9.2

  • Weight (mean ± SD, median (IQR), median (range)): 62.1 ± 11.7

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 50/4/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 33.3/NA

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA

  • Use of perioperative opioids (if yes, which?): 387.5 µg fentanyl, 9.16 mg postoperative morphine

  • Type of surgery: laparoscopy or other gynaecological surgery (laparotomy or vaginal hysterectomy)


Dolasetron (25 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 60

  • Received treatment (n): NA

  • Analysed (n): 60

  • Age (mean ± SD, median (IQR), median (range)): 38.2 ± 9.1

  • Weight (mean ± SD, median (IQR), median (range)): 61.8 ± 10.5

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 57/3/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 20.0/NA

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA

  • Use of perioperative opioids (if yes, which?): 347.9 µg fentanyl, 9.67 mg postoperative morphine

  • Type of surgery: laparoscopy or other gynaecological surgery (laparotomy or vaginal hysterectomy)


Dolasetron (50 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 54

  • Received treatment (n): NA

  • Analysed (n): 54

  • Age (mean ± SD, median (IQR), median (range)): 38.5 ± 8.1

  • Weight (mean ± SD, median (IQR), median (range)): 63.9 ± 11.7

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 46/8/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 14.8/NA

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 105.7

  • Use of perioperative opioids (if yes, which?): 345.9 µg fentanyl, 11.24 mg postoperative morphine

  • Type of surgery: laparoscopy or other gynaecological surgery (laparotomy or vaginal hysterectomy)


Dolasetron (100 mg group)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 59

  • Received treatment (n): NA

  • Analysed (n): 59

  • Age (mean ± SD, median (IQR), median (range)): 38.3 ± 8.5

  • Weight (mean ± SD, median (IQR), median (range)): 61.4 ± 12.0

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 53/6/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 30.5/NA

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA

  • Use of perioperative opioids (if yes, which?): 311.9 µg fentanyl, 6.51 mg postoperative morphine

  • Type of surgery: laparoscopy or other gynaecological surgery (laparotomy or vaginal hysterectomy)


Included criteria: females between 18 and 55 years of age, ASA I or II, scheduled to undergo laparoscopy or other gynaecological surgery (laparotomy or vaginal hysterectomy) with general anaesthesia as inpatients
Excluded criteria: pregnant or lactating; surgical procedure scheduled during menstruation; significant history of hepatic, renal, cardiovascular, or metabolic disease; significant abnormalities in pre‐study laboratory tests; treatment with antiarrhythmic drugs; vomiting from organic etiologies (i.e. bowel obstruction); vomiting or administration of a potential antiemetic drug within 24 hours before study drug administration; scheduled to receive an intragastric tube postoperatively; had taken an investigational drug within 21 days of study initiation; addicted to alcohol or other abusive substance
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender): no; (history of motion sickness, duration of anaesthesia, non‐smoker): unclear; (history of PONV, perioperative opioids): yes.
Interventions Intervention characteristics
Placebo

  • Dose: saline

  • Time point of administration: at end of N₂O administration

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): e.g. metoclopramide, cyclizine


Dolasetron (12.5 mg group)

  • Dose: 12.5 mg

  • Time point of administration: at end of N₂O administration

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): e.g. metoclopramide, cyclizine


Dolasetron (25 mg group)

  • Dose: 25 mg

  • Time point of administration: at end of N₂O administration

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): e.g. metoclopramide, cyclizine


Dolasetron (50 mg group)

  • Dose: 50 mg

  • Time point of administration: at end of N₂O administration

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): e.g. metoclopramide, cyclizine


Dolasetron (100 mg group)

  • Dose: 100 mg

  • Time point of administration: at end of N₂O administration

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): e.g. metoclopramide, cyclizine
Outcomes Complete response (no PONV) in 24 hours

  • Outcome type: dichotomous outcome


Subjects with any SAE (0 to 24 hours)

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Sedation/drowsiness (0 to 24 hours)

  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)

  • Outcome type: general notes on side effects
Identification Sponsorship source: supported by a grant from Hoechst Marion Roussel, Inc., Strasbourg, France
Country: France
Setting: inpatient, multi‐centre (10)
Author's name: Pierre Diemunsch
Institution: Department of Anesthesiology, Les Hopitaux Universitaires de Strasbourg, Strasbourg, France
Email: NA
Address: Hopitaux Universitaires, 1, place de l’Hopital, 67000 Strasbourg, France
Duration of study: NA
Language: English
Study's primary outcome: complete response over 24 hours
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "followed cessation of N,O. Patients were stratified and randomly assigned via sealed envelope assignment from..."
Judgement comment: no further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Quote: "...via sealed envelope assignment"
Judgement comment: not stated; "sequentially numbered, opaque, sealed envelopes" (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "...or 100 mg dolasetron mesilate. Ampules containing 10 ml of placebo (sterile saline) or dolasetron mesilate in concentrations of 2.5 mg/ml, 5 mg/ml, 10 mg/ml, or 20 mg/ml were provided by Hoechst Marion Roussel, Inc. To achieve the required dose for each patient, 5 ml of solution was withdrawn from the appropriate ampule, diluted to 50 ml with sterile saline for injection, and administered IV..."
Judgement comment: no detailed information on blinding of anaesthesiologists; syringes not stated identical; not clear who is preparing the study drugs
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 High risk Quote: "study at 10 investigative sites. There were no statistically significant differences among the five treatment groups with respect to age, weight, height, ASA physical status, and posttreatment administration of morphine (Table I). The difference in the proportion of patients with and without a history of PONV approached statistical significance ($I = 0.053); the 50 mg dolasetron mesilate treatment group had the lowest percentage of patients with a history of PONV (15%), and the placebo group had the highest percentage (36%). As shown in Table 2"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender): no; (history of motion sickness, duration of anaesthesia, non‐smoker): unclear; (history of PONV, perioperative opioids): yes