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Trial Title:
Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy
NCT ID:
NCT06406829
Condition:
Postoperative Pain
Analgesia
Supratentorial Brain Tumor
Conditions: Official terms:
Agnosia
Pain, Postoperative
Dexmedetomidine
Analgesics
Conditions: Keywords:
multimodal analgesia
Postoperative acute pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Dexmedetomidine
Description:
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.
Arm group label:
Local analgesic techniques + dexmedetomidine group
Arm group label:
Placebo local analgesic techniques and dexmedetomidine group
Other name:
DEX
Intervention type:
Drug
Intervention name:
Normal saline
Description:
In the placebo group, the 0.9% saline is administered with the same volume at the same
speed as the dexmedetomidine group
Arm group label:
Local analgesic techniques and placebo dexmedetomidine group
Arm group label:
Placebo local analgesic techniques and placebo dexmedetomidine group
Other name:
NS
Intervention type:
Other
Intervention name:
Local analgesic techniques
Description:
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.
Arm group label:
Local analgesic techniques + dexmedetomidine group
Arm group label:
Local analgesic techniques and placebo dexmedetomidine group
Other name:
LAT
Intervention type:
Other
Intervention name:
no Local analgesic techniques
Description:
No Local analgesic techniques will be given.
Arm group label:
Placebo local analgesic techniques and dexmedetomidine group
Arm group label:
Placebo local analgesic techniques and placebo dexmedetomidine group
Other name:
NLAT
Summary:
Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe
perioperative pain. Inadequate perioperative pain relief has been associated with
increased blood pressure and intracranial pressure, favoring bleeding and cerebral
cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain
relief, eliminates the side effects of opioid drugs and no influence for neurological
function. Previous studies have proposed a multimodal analgesic strategy, combining
analgesics and local anaesthesia, it is expected to achieve the above benefits.
Detailed description:
The trial has been designed to analyze the efficacy of local analgesic techniques and
dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This
randomized clinical trial aims to enroll 2000 patients, which will be randomized to one
of 4 groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged from 18 to 65 years
- American Society of Anesthesiologists physical status I to III
- Scheduled to undergo elective supratentorial tumor resection
Exclusion Criteria:
- Incision-area skin infection
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Beijing Tiantan Hospital
Agency class:
Other
Source:
Beijing Tiantan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06406829
