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

Arteriovenous Malformation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02552459
• Other study ID #: FirstSunYetSen-jn2015
• Status: Recruiting
• Phase: Phase 4
• First received: May 26, 2015
• Last updated: October 16, 2016
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Liu Yi, master
• Phone: 13632391455
• Email: liuyisysu[@]126.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Malformation
• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma

Intervention

Drug:
• Sufentanil
sufentanil 150µg, intravenous administration during post-operative 72 hours.
• dexmedetomidine 1
dexmedetomidine 0.05µg/kg/h, Continuous intravenous injection for 72 hours after operation
• dexmedetomidine 2
dexmedetomidine 0.1µg/kg/h, Continuous intravenous injection for 72 hours after operation
• dexmedetomidine 3
dexmedetomidine 0.15µg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Sun Yetsen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes