Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant

June 27, 2016 updated by: Mahidol University
The purpose of this study is to determine the recovery profiles after general anesthesia in patient undergoing anterior cervical spine surgery. This study will compare the Riker sedation agitation scores between two groups, with or without dexmedetomidine as an anesthetic adjuvant.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-3
  • elective case for ACDF surgery
  • plan for extubation after surgery

Exclusion Criteria:

  • SBP>140 mmHg
  • CAD
  • HR<50 BPM, heart block
  • motor weakness > grade 4
  • BMI >30
  • allergic to dexmedetomidine, fentanyl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dexmedetomidine
Demedetomidine infusion (2mcg/ml); loading 0.5 mcg/kg for 30 min (BW/2 ml/h for 30 min), then 0.5 mcg/kg (BW/4 ml/h) until 30 minutes before finish the operation.
Drug: Dexmedetomidine
Demedetomidine infusion (2mcg/ml); loading 0.5 mcg/kg for 30 min (BW/2 ml/h for 30 min), then 0.5 mcg/kg (BW/4 ml/h) until 30 minutes before finish the operation.
Other Names:
  • Precedex
PLACEBO_COMPARATOR: NSS
NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.
Other: NSS
NSS infusion; loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.
Other Names:
  • Narmal saline, 0.9%NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Riker sedation agitation scores
Time Frame: before extubation

After finish the operation, Desflurane will be stopped. All patients will be received the neuromuscular reversal drugs and TOF ratio > 0.9. All patients will be evaluated by Riker sedation agitation score before extubation and re-evaluated again at 15 minutes after extubation.

Riker sedation agitation scores

  1. Dangerous agitation: trying to get out of bed, pulling out tube, thrashing
  2. Very agitated: may require physical restraint, unable to calm with verbal instructions.
  3. Agitated: mild agitation and anxiety but calm down with verbal instructions.
  4. Calm and cooperative: aroused easily and follows commands
  5. Sedated: difficult to aroused, but does arouse to verbal or physical stimuli, able to follow simple commands
  6. Very sedated: does not follow commands but arouses to physical stimulation
  7. Unarousable: little or no response to noxious stimuli
before extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fentanyl consumption
Time Frame: during surgery
After finish the operation, the total of fentanyl consumption during the operation will be recorded.
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Busara Sirivanasandha, MD, Department of Anesthesiology, Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (ESTIMATE)

June 30, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 018/2559(EC1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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