Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy
NCT ID: NCT06406829
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2000 participants
INTERVENTIONAL
2025-03-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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Local analgesic techniques + dexmedetomidine group
The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. The patients also will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery.
Dexmedetomidine
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery.
Local analgesic techniques
The 10ml 1% ropivacaine will be diluted into a 20ml syringe . As for scalp nerve block, each nerve will be blocked separately with 1-2 mL 0.5% ropivacaine.
Local analgesic techniques and placebo dexmedetomidine group
The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery.
Normal saline
In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group
Local analgesic techniques
The 10ml 1% ropivacaine will be diluted into a 20ml syringe . As for scalp nerve block, each nerve will be blocked separately with 1-2 mL 0.5% ropivacaine.
Placebo local analgesic techniques and dexmedetomidine group
The patients in this group will not receive scalp nerve block. The patients will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery.
Dexmedetomidine
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery.
no Local analgesic techniques
No Local analgesic techniques will be given.
Placebo local analgesic techniques and placebo dexmedetomidine group
The patients in this group will not receive scalp nerve block before surgery . For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine group during surgery and for 48 hours after surgery.
Normal saline
In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group
no Local analgesic techniques
No Local analgesic techniques will be given.
Interventions
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Dexmedetomidine
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery.
Normal saline
In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group
Local analgesic techniques
The 10ml 1% ropivacaine will be diluted into a 20ml syringe . As for scalp nerve block, each nerve will be blocked separately with 1-2 mL 0.5% ropivacaine.
no Local analgesic techniques
No Local analgesic techniques will be given.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical status I to III
* Scheduled to undergo elective supratentorial tumor resection
Exclusion Criteria
* A history of previous craniotomy
* Allergy to study medications
* A history of preoperative change in consciousness or cognitive function
* Severe hepatic or renal dysfunction
* Severe bradycardia (heart rate\<40 beats/min)
* Sick sinus syndrome or second- to-third degree atrioventricular block
18 Years
65 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Yuming Peng
Deputy chief of Department of Anesthesiology
Principal Investigators
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Yuming Peng, Dr
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Central Contacts
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Other Identifiers
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2024007
Identifier Type: -
Identifier Source: org_study_id
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