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.
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.
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
- 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).
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). 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.
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)
Surgeon satisfaction as regard surgical field. Postoperative VAS score and time for 1st rescue analgesia. Total analgesic consumption in first 24 hours postoperative.
- 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.
- 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).
- 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.
- First posted30 Apr 2025
- Study start10 Mar 2024
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yara Sa Ghareb, MBBCH, Principal investigator, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06951256
- Acronym / sponsor ID
- FMASU MS78/2024
- Keywords
- Scalp block, Mean arterial pressure stability, Dexmedetomidine, Craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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).
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SB (n =18 patient) will receive scalp block with Bupivacaine alone. | Active comparator | Drug: Scalp block with bupivacaine aloneIn 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). |
| Group SD (n =18 patient) will receive scalp block with dexmedetomidine as an adjuvant to Bupivacaine | Active comparator | Drug: Scalp block by adding dexmedetomidine as an adjuvant to bupivacaineIn 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged from 18 to 65 years.
- Patients ASA I or II undergoing supratentorial elective planned craniotomies.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp block with bupivacaine aloneAlso: Traditional scalp blockIn 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 | Drug | Group SB (n =18 patient) will receive scalp block with Bupivacaine alone. |
| Scalp block by adding dexmedetomidine as an adjuvant to bupivacaineAlso: Scalp block by dexmedetomidine, Dexmedetomidine, Dexmedetomidine as an adjuvant to bupivacainelocal 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 | Drug | Group SD (n =18 patient) will receive scalp block with dexmedetomidine as an adjuvant to Bupivacaine |
Primary outcome
Intraoperative mean arterial pressure measured after Mayfeild insertion during craniotomies.
Time frame: During the operation
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.
1 secondary outcome
Surgeon satisfaction as regard surgical field. Postoperative VAS score and time for 1st rescue analgesia. Total analgesic consumption in first 24 hours postoperative.
Time frame: During 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Yes. After paper publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yara Sa Ghareb, MBBCH principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
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.