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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Current Primary Outcome: Pain on the VAS scale [ Time Frame: within the following 72 hours after surgery ]

measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital, Sun Yat-Sen University

Dates:
Date Received: May 26, 2015
Date Started: September 2015
Date Completion: December 2016
Last Updated: October 16, 2016
Last Verified: October 2016