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DexmedetomidineNCT06951256

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

A study testing Scalp block with bupivacaine alone and Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine in people with Dexmedetomidine and Craniotomy, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dexmedetomidine, Craniotomy, Regional Anesthesia
What is being tested?
Scalp block with bupivacaine alone and Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteEgypt
Study dates
10 Mar 2024to 10 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams university

    Cairo, Egypt, 11111

Other trials in Egypt

About this study

Official title: Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Intraoperative Mean Arterial Pressure Stability in Adult Patients Undergoing Craniotomy

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

Read the detailed description
  1. Preoperative settings:

Complete history taking and full physical examination. Routine preoperative investigations was done to all patients including laboratory investigations (complete blood picture, liver function tests, prothrombin time and partial thromboplastin time) and other as needed by the patient condition.

Written informed consent was obtained from all participants prior to the study. Patients was educated visual analogue score for pain (VAS), which consisted of 10c.m line, with two end points (where 0=no pain and 10=worst pain).

  1. Intraoperative settings:

Electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximeter (SpO2) will be applied, and baseline readings were taken before induction, no sedation was given.

Anesthesia was induced after a period of preoxygenation with 100% oxygen for 2-3 minutes with intravenous injection of fentanyl 2 µg/kg .propofol 2 mg/kg ) and a muscle relaxant (Atracurium) 0.5 mg/kg after loss of patient consciousness.

After endotracheal intubation, intubation was confirmed by ETCO2 and bilateral auscultation of the chest.

Anesthesia was maintained with 60% oxygen mixed with air and isoflurane 1-2%. Lungs were ventilated using volume-controlled ventilation with tidal volumes and respiratory rate adjusted to maintain end tidal CO2 at 35-40 mmHg.

Following anesthesia induction, a continuous invasive blood pressure monitoring was initiated through radial 20-gauge arterial catheterization, as well as urine output through bladder catheterization.

Sampling method:

The patients were randomly divided into two equal groups using a computerized generated list (closed opaque sealed envelope).

Group SB (n =18 patient) received scalp block with Bupivacaine alone. Group SD (n =18 patient) received scalp block with Dexmedetomidine as an adjuvant to Bupivacaine.

In both group:

Scalp nerve block was done by anesthesiologist who is blind to the drug being injected and under complete septic 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 as follow :

The patient lied supine on the table while the performing operator usually stands at the head end facing the feet.

The supraorbital and supratrochlear nerves were blocked with 2 mL of solution as they emerge from the orbit with needle introduced above the eyebrow perpendicular to the skin. The supraorbital notch was located by palpation, and the needle was introduced perpendicularly 1 cm medial to the notch.

The auriculotemporal nerves was performed with the patient's head turned to one side so that the side to be blocked faces upward with 3 mL of solution injected 1.5 cm anterior to the ear at the level of the tragus; the needle was introduced perpendicular to the skin and infiltration made deep to the fascia and superficially as the needle withdrawn. The superficial temporal artery should be palpated to avoid intra-arterial injection. Negative aspiration is a must for this block.

The post auricular branches of the greater auricular nerves were blocked with 2 mL of solution between skin and bone, 1.5 cm posterior to the ear at the level of the tragus The needle was inserted at 90 degrees till bony contact is made, upon which it is withdrawn, and subcutaneous injection was performed.

The greater, lesser, and third occipital nerves were blocked with 3 mL of solution with infiltration along the superior nuchal line, approximately halfway between the occipital protuberance and the mastoid process.

In Group SB: (LA) was done by 20ml of Bupivacaine 0.25%.

While Group SD:

local infiltration of total volume 20ml which include (Bupivacaine 0.25%. + Dexmedetomidine 1mcg/kg) was done.

In both group maximal dose of Bupivacaine didn't not exceed (2.5 mg/kg) . 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 used.

Mayfield placement in all patients was done 15 minutes after scalp block was given.

*Both blocks was done \& or supervised by an expert all through. At the end of the surgery, the residual neuromuscular block was be reversed with intravenous injection of neostigmine (0.05 mg/kg) with atropine (0.01 mg/kg), Endotracheal tube extubation was done and then the patient was transferred to Postoperative anesthesia care unit (PACU).

Being tested
Scalp block with bupivacaine alone, Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine
Keywords
Scalp block, Mean arterial pressure stability, Dexmedetomidine, Craniotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scalp block with bupivacaine aloneDrug

    Also called Traditional scalp block

    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

  • Scalp block by adding dexmedetomidine as an adjuvant to bupivacaineDrug

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

    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

Study groups in NCT06951256
Study groupRoleWhat they receive
Group SB (n =18 patient) will receive scalp block with Bupivacaine alone.Active comparatorIn 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).
Receives: Drug: Scalp block with bupivacaine alone
Group SD (n =18 patient) will receive scalp block with dexmedetomidine as an adjuvant to BupivacaineActive comparatorIn 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).
Receives: Drug: Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the operation

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

    1. Heart rate 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.
    2. Intraoperative surgeon satisfaction: Surgeon satisfaction regard surgical field was assessed and recorded according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor).
    3. Assessment of post-operative pain:

    Post operatively, the patient was transferred to the PACU where pain intensity was evaluated on a (0-10) visual analog scale (VAS)

    Measured: During 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start10 Mar 2024
  3. Primary completion10 Sep 2024
  4. Study completion10 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06951256
Sponsor's protocol ID
FMASU MS78/2024
Status last verified
Mar 2024
First submitted
4 Apr 2025
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After paper publication

Questions about this trial

What is this clinical trial studying?

A study testing Scalp block with bupivacaine alone and Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine in people with Dexmedetomidine and Craniotomy, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative mean arterial pressure measured after Mayfeild insertion during craniotomies. (time frame: During the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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