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Comparing the effectiveness of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy surgery

Comparing the effectiveness of propofol-remifentanil with propofol-dexmedetomidine in reducing pain after awake craniotomy surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151221025641N5
Enrollment
64
Registered
2023-03-25
Start date
2023-04-09
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Awake craniotomy. Other disorders of brain in diseases classified elsewhere

Interventions

Intervention 1: Intervention group: (dexmedetomidine infusion with a LD of 1 µg/kg/h for 15 minutes and then a MD of 0.2 µg/kg/h). Intervention 2: Control group: (propofol1% infusion with a LD of 250

Sponsors

Tehran University of Medical Sciences
Lead Sponsor
Anesthesiology, critical care and pain management research center
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: The patient should be a candidate for craniotomy surgery using the sleep-awake-asleep method; The patient does not have a previous craniotomy history; The patient does not have a contraindication for full anesthesia; The patient's age is between 20 and 50 years; The patient does not have a history of allergy to any of the drugs under study.

Exclusion criteria

Exclusion criteria: In addition to craniotomy, the patient needs to perform another surgery at the same time; Pregnancy; Breast feeding; The patient has simultaneously heart, renal or liver failure; Severe obesity (BMI>30 kg/m2);

Design outcomes

Primary

MeasureTime frame
Pain intensity. Timepoint: On 2,6,12,24,48 hours. Method of measurement: VAS scale.

Secondary

MeasureTime frame
Diclofenac suppository dosage required. Timepoint: On 2,6,12,24,48 hours. Method of measurement: Medical record.;The duration of hospitalization until the patient is able to move. Timepoint: The entire length of hospitalization. Method of measurement: Medical record.;Nausea and vomiting. Timepoint: On 2,6,12,24,48 hours. Method of measurement: Patient examination.;Vertigo. Timepoint: On 2,6,12,24,48 hours. Method of measurement: Patient examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Baniasad

Tehran University of Medical Sciences

shima.baniassad@gmail.com+98 21 6312 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026