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The effect of propofol-fentanyl compared with sevoflurane-fentanyl on the incidence of postoperative nausea vomiting after infratentorial craniotomy: A randomized controlled trial

The effect of propofol-fentanyl compared with sevoflurane-fentanyl on the incidence of postoperative nausea vomiting after infratentorial craniotomy: A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211013004
Enrollment
62
Registered
2021-10-13
Start date
2021-10-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient who undergoes infratentorial craniotomy Infratentorial craniotomy Postoperative nausea vomiting Intravenous anesthesia Inhalation anesthesia

Interventions

Maintenance of anesthesia during the operation is total intravenous anesthesia with target controlled infusion (TCI) propofol 4-6 mcg/ml (Schnider model) and fentanyl 0.2-0.5 mcg/kg/hr.,Maintenance of
Experimental Other,Active Comparator Other
Total intravenous anesthesia,Inhalation

Sponsors

Faculty of Medicine, Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient who undergoes infratentorial craniotomy 2. The American Society of Anesthesiologists (ASA) Physical Status Classification I-III 3. Expected to extubate after surgery

Exclusion criteria

Exclusion criteria: 1. Patient who refuse to be included in the project. 2. Anesthesia without surgery. 3. Patient who receive combined intravenous anesthesia and inhaled anesthesia. 4. Patient with increased intracranial pressure. 5. Patient with abnormal liver function or chronic alcoholism. 6. Patient who is suspected for malignant hyperthermia 7. Patient with opioid allergy. 8. Patient who receive antiemetic prophylaxis within 24 hours before surgery. 9. Patient with history of chemotherapy within 4 weeks before surgery or radiation within 8 weeks before surgery. 10. Patient who remain intubated after surgery

Design outcomes

Primary

MeasureTime frame
Postoperative nausea/vomitting 24 hours postoperatively PONV scoring

Secondary

MeasureTime frame
Postoperative nausea/vomitting 0, 0.5,1,2,6,12,48 hours postoperatively PONV scoring,Brain relaxation before dura opening and during surgery Brain relaxation score assessed by surgeon,Antiemetic medication 48 hours post operative Total amount of antiemetic medication patient received,Mean blood pressure, heart rate baseline, intubation, dural opening, every hour during surgery, dural closure, extubation Mean blood pressure, heart rate,Medication for hemodynamic control during the surgery Amount of norepinephrine, labeterol , esmolol,Anesthesia and Surgical time during the operation Time of anesthesia and Surgery,Time to follow command, time to eye opening, time to extubation After stopping the anesthetic agent time after the cessation of the anesthetic agent to time when patient follow command, open their eyes and extubatne

Countries

Thailand

Contacts

Public ContactApisara Wongwaikijphaisant

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn university

apisara.sai@gmail.com66841271235

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026