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

Primary Purpose

Cervical Spondylosis

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Dexmedetomidine

NSS

About this trial

This is an interventional treatment trial for Cervical Spondylosis focused on measuring anterior cervical spine surgery, ACDF, Dexmedetomidine, Anesthesia, Agitation, Riker sedation agitation scores

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

NSS

Arm Description

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.

NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.

Outcomes

Primary Outcome Measures

Riker sedation agitation scores

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

Secondary Outcome Measures

Fentanyl consumption

After finish the operation, the total of fentanyl consumption during the operation will be recorded.

Full Information

NCT ID

NCT02819089

First Posted

June 15, 2016

Last Updated

June 27, 2016

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02819089

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Spondylosis

Keywords

anterior cervical spine surgery, ACDF, Dexmedetomidine, Anesthesia, Agitation, Riker sedation agitation scores

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine

Arm Type

Active Comparator

Arm Description

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.

Arm Title

NSS

Arm Type

Placebo Comparator

Arm Description

NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

NSS

Other Intervention Name(s)

Narmal saline, 0.9%NaCl

Intervention Description

NSS infusion; loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.

Primary Outcome Measure Information:

Title

Riker sedation agitation scores

Description

Time Frame

before extubation

Secondary Outcome Measure Information:

Title

Fentanyl consumption

Description

After finish the operation, the total of fentanyl consumption during the operation will be recorded.

Time Frame

during surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Busara Sirivanasandha, MD

Phone

+6624197990

busarasiri@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Manee Raksakietisak, MD

Phone

+6624127990

manee95@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Busara Sirivanasandha, MD

Organizational Affiliation

Department of Anesthesiology, Siriraj Hospital, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital, Mahidol University

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Busara Sirirvanadandha, MD

Phone

+66851429656

busarasiri@yahoo.com

First Name & Middle Initial & Last Name & Degree

Manee Raksakietisak, MD

Phone

+668-1488-0620

manee95@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

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

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