Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block vs Bupivacaine Alone for Hemodynamics Stability in Craniotomy

NCT06951256 | Completed DMC

• 1 other identifier: FMASU MS78/2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator tested the effect of dexmedetomidine as an adjuvant to bupivacaine compared to bupivacaine alone in mean arterial pressure stability in adult patients undergoing craniotomy

Conditions

Dexmedetomidine; Craniotomy; Regional Anesthesia; Mean Arterial Pressure Stability

Keywords

Scalp block; Mean arterial pressure stability; Dexmedetomidine; Craniotomy

Outcome Measures

Primary Outcomes (1)

• Intraoperative mean arterial pressure measured after Mayfeild insertion during craniotomies.

  Mean blood pressure (MAP) was monitored continuously and recorded at Base line, before Mayfield placement, after 5mins of Mayfield insertion and at the end of surgery. The hemodynamic parameters at each step of recording were compared between the two groups.

  During the operation

Secondary Outcomes (1)

• Surgeon satisfaction as regard surgical field. Postoperative VAS score and time for 1st rescue analgesia. Total analgesic consumption in first 24 hours postoperative.

  During 24 hours

Study Arms (2)

Group SB (n =18 patient) will receive scalp block with Bupivacaine alone.

ACTIVE COMPARATOR

In Group SB: 20 ml of Bupivacaine 0.25% was given Scalp nerve block was done under complete aseptic condition where local infiltration of local anesthetic (LA) was done guided by bony superficial landmarks to block the supraorbital, supratrochlear, auriculotemporal, occipital, and post auricular branches of the greater auricular nerves. In both group maximal dose of Bupivacaine was not exceed (2.5 mg/kg).

Drug: Scalp block with bupivacaine alone

Group SD (n =18 patient) will receive scalp block with dexmedetomidine as an adjuvant to Bupivacaine

ACTIVE COMPARATOR

In group SD: local infiltration of total volume 20 ml which include (Bupivacaine 0.25%. + Dexmedetomidine 1 mcg/kg) was given. Dexmedetomidine preparation was done by 2 ml (200 mcg) diluted by 18 ml normal saline in 20 ml syringe as 1 ml was contained 10 mcg and was used. Scalp block was given by the same way as group SB. In both group maximal dose of Bupivacaine was not exceed (2.5 mg/kg).

Drug: Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine

Interventions

Scalp block with bupivacaine alone DRUG

In Group SB: (LA) was done by 20ml of Bupivacaine 0.25%. maximal dose of Bupivacaine did not exceed (2.5 mg/kg) Scalp nerve block will be done by anesthesiologist who is blind to the drug being injected and under complete septic condition where local infiltration of local anesthetic (LA) will be done guided by bony superficial landmarks to block the supraorbital, supratrochlear, auriculotemporal, occipital, and post auricular branches of the greater auricular nerves

Also known as: Traditional scalp block

Group SB (n =18 patient) will receive scalp block with Bupivacaine alone.

Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine DRUG

local infiltration of total volume 20ml which include (Bupivacaine 0.25%. + Dexmedetomidine 1mcg/kg) was done Dexmedetomidine preparation was done by 2ml (200 mcg) diluted by 18 ml normal saline in 20 ml syringe as 1ml was contain 10 mcg and injected at same points as above

Also known as: Scalp block by dexmedetomidine, Dexmedetomidine, Dexmedetomidine as an adjuvant to bupivacaine

Group SD (n =18 patient) will receive scalp block with dexmedetomidine as an adjuvant to Bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged from 18 to 65 years.
• Patients ASA I or II undergoing supratentorial elective planned craniotomies.

You may not qualify if:

• Patients refused to participate in the study.
• Patients with cardiovascular diseases such as hypertension or low cardiac reserve.
• History or known allergy to the used local anesthetic or opioids.
• Patient could not understand a visual analog scale (VAS).
• Bleeding disorders.
• Evidence of local infection at site of injection. 7. Emergency craniotomy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yara Sa Ghareb, MBBCH

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 30, 2025
• Study Start: March 10, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: April 30, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)