Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery

Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study

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

Study Overview

• Status: Unknown
• Conditions: Arteriovenous Malformation
• Intervention / Treatment: Drug: Sufentanil; Drug: dexmedetomidine 1; Drug: dexmedetomidine 2; Drug: dexmedetomidine 3

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • the First Affiliated Hospital of Sun Yetsen University
      • Contact: Yi Liu, Master; Phone Number: +86 13632391455; Email: liuyisysu@126.com
      • Contact: Nan Jiang, professor; Phone Number: +86 20 28823350; Email: NJiang_sysu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sufentanil; sufentanil 150μg，intravenous administration during the following 72 hours after operation.	Drug: Sufentanil; sufentanil 150μg， intravenous administration during post-operative 72 hours.; Other Names: Sufentanyl
Experimental: sufentanil&dexmedetomidine 1; sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation.	Drug: Sufentanil; sufentanil 150μg， intravenous administration during post-operative 72 hours.; Other Names: Sufentanyl; Drug: dexmedetomidine 1; dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation; Other Names: Dex,Dexmedetomidine
Experimental: sufentani&dexmedetomidine 2; sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation.	Drug: Sufentanil; sufentanil 150μg， intravenous administration during post-operative 72 hours.; Other Names: Sufentanyl; Drug: dexmedetomidine 2; dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation; Other Names: Dex,Dexmedetomidine
Experimental: sufentanil&dexmedetomidine 3; sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation.	Drug: Sufentanil; sufentanil 150μg， intravenous administration during post-operative 72 hours.; Other Names: Sufentanyl; Drug: dexmedetomidine 3; dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.; Other Names: Dex,Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on the VAS scale	measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。	within the following 72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure(BP)(mmHg)	measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h	within the following 72 hours after surgery
heart rate(HR) (/min)	measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h	within the following 72 hours after surgery
spO2(%)	measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h	within the following 72 hours after surgery
breath(/min)	measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h	within the following 72 hours after surgery
sedation level on ramsay sedation score	measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h	within the following 72 hours after surgery
vomit times	measure vomit times on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h	within the following 72 hours after surgery
nausea	measure whether nausea exists on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h	within the following 72 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
dose of rescue tramadol	measure the dose of tramadol using as rescue drug on post-operative 24h、48h、72h	within the following 72 hours after surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Jiang Nan, doctor, The First Affiliated Hospital, Sun Yat-sen Unniversity; Principal Investigator: Shao Xinxin, master, The First Affiliated Hospital, Sun Yat-sen Unniversity

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 16, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: dexmedetomidine; patient controlled analgesia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Dexmedetomidine; Sufentanil; Dsuvia
• Other Study ID Numbers: FirstSunYetSen-jn2015