Clinical trial NCT02552459: Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery
Official title: Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arteriovenous Malformation
Keywords: dexmedetomidine
patient controlled analgesia
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.

Detailed description: Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.

Eligibility criteria: Inclusion Criteria:

1. patients undergoing venous malformation embolization operation through general anesthesia.
2. aged 18-65 years old.
3. operating time varies 1-4h,and extubation after the operation.

Exclusion Criteria:

1. long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.
2. known for dexmedetomidine or other drugs allergy in this study.
3. cannot communicate.
4. preoperative systolic blood pressure \<90 mmHg, or the heart rate \<50/min.

Primary outcomes:
measure: Pain on the VAS scale
timeFrame: within the following 72 hours after surgery
Secondary outcomes:
measure: blood pressure(BP)(mmHg)
timeFrame: within the following 72 hours after surgery
measure: heart rate(HR) (/min)
timeFrame: within the following 72 hours after surgery
measure: spO2(%)
timeFrame: within the following 72 hours after surgery
measure: breath(/min)
timeFrame: within the following 72 hours after surgery
measure: sedation level on ramsay sedation score
timeFrame: within the following 72 hours after surgery
measure: vomit times
timeFrame: within the following 72 hours after surgery
measure: nausea
timeFrame: within the following 72 hours after surgery
Other outcomes:
measure: dose of rescue tramadol
timeFrame: within the following 72 hours after surgery
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Sun Yetsen University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital, Sun Yat-sen Unniversity
name: Jiang Nan, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital, Sun Yat-sen Unniversity
name: Shao Xinxin, master
role: PRINCIPAL_INVESTIGATOR
References: