Ketamine Versus Dexmedetomidine as an Adjuvant in Scalp Block in Supratentorial Brain Tumor Excision Surgeries

NCT07698665 | Recruiting

• 1 other identifier: MS-483-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Supratentorial brain tumor surgeries are associated with significant nociceptive stimulation and postoperative pain, which may adversely affect patient outcomes. Scalp block has emerged as an effective regional anesthetic technique to improve analgesia and reduce opioid consumption. Objective: To compare efficacy of ketamine versus dexmedetomidine as adjuvants to bupivacaine in scalp blocks for supratentorial brain tumor surgeries, focusing on analgesia, opioid consumption, and hemodynamic stability. Methods: This randomized double-blinded controlled trial included 80 patients undergoing supratentorial tumor excision, allocated equally into two groups: Group K received bupivacaine with ketamine (2 mg/kg), and Group D received bupivacaine with dexmedetomidine (1 µg/kg). Intraoperative hemodynamics, fentanyl consumption, postoperative pain scores (NRS), analgesic requirements, and complications were assessed.

Conditions

Regional Anesthesia Morbidity; Supratentorial Brain Tumor; Acute Pain

Keywords

Scalp block; Dexemetomedine; Supratentorial

Outcome Measures

Primary Outcomes (1)

• Analgesic efficacy of dexmedetomidine versus ketamine as adjuvants in scalp blocks

  Compare analgesic efficacy of dexmedetomidine versus ketamine as adjuvants in scalp blocks for supratentorial tumor resection by measuring total intraoperative fentanyl consumption (in µg).

  6 hours

Secondary Outcomes (6)

• Compare the time duration after extubating to request the first analgesia.

  24 hours

• Total analgesic consumption.

  24 hours

• NRS pain score

  24 hours

• Nausea and vomiting

  24 hours

• Side effects

  24 hours

Study Arms (2)

Dexmedetomidine (D)

EXPERIMENTAL

Patients will receive a scalp block with a 20 ml syringe containing 1 mg/kg of 0.5% bupivacaine and 1 µg/kg of dexmedetomidine, with the remainder filled with saline.

Drug: Scalp Block with Bupivacaine

Ketamine (K):

ACTIVE COMPARATOR

Patients will receive a scalp block with a 20 ml syringe containing 1 mg/kg of 0.5% bupivacaine and 2 mg/kg of ketamine, with the rest filled with saline. The syringes will be prepared by an anesthesia technician and handed blindly to the anesthetist to administer the block.

Drug: Scalp Block with Bupivacaine

Interventions

Scalp Block with Bupivacaine DRUG

After induction, bilateral scalp blocks were performed using a 23G needle, with local anesthetic infiltrated around supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, lesser occipital, greater occipital, and great auricular nerves, 2-3 mL per nerve.

Dexmedetomidine (D); Ketamine (K):

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 20 to 60 years, both sexes, American Society of Anesthesiologists (ASA) physical status II-III, Supratentorial tumor excision, Supine Position.
• and operation time: less than 6 hours.

You may not qualify if:

• Patient refusal, disturbed consciousness level (Glasgow Coma Scale \[GCS\] \< 15). Patients who required reintubation during the study period, those not extubated. immediately after surgery, or those who awoke with neurological deficits impairing. pain assessments were excluded from the final analysis, history of psychotic disorders or previous surgeries, Poor cognitive function.
• Postictal state or uncontrolled/recurrent seizures, known allergy to dexmedetomidine or ketamine, difficult intubation (Mallampati score \> III) or multiple intubation attempts, operation duration \> 6 hours, renal dysfunction (creatinine \> 1.2 mg/dL, BUN \> 20 mg/dL), heart block and patients with chronic headache disorders or those receiving chronic analgesic therapy (for \>3 months) were excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo university

Cairo, Governorate, 002, Egypt

RECRUITING

Cairo university Hospitals. kasralainy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2026
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

EG (2)