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

ConditionsRegional Anesthesia MorbiditySupratentorial Brain TumorAcute Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age from 20 to 60 years, both sexes, American Society of Anesthesiologists (ASA) physical status II-III, Supratentorial tumor excision, Supine Position.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine (D)Experimental treatment 1 intervention
Group B: Ketamine (K):Active comparator 1 intervention

Trial outcomes

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).

Time frame
6 hours

Secondary outcomes

1

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

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

Time frame
24 hours
2

Total analgesic consumption.

Total analgesic consumption in intraoperative and postoperative period till 24 hours.

Time frame
24 hours
3

NRS pain score

NRS pain score at various time points in the postoperative period till 24 hours.

Time frame
24 hours
4

Nausea and vomiting

Nausea and vomiting incidence

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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