Dexmedetomidine vs Control on Attenuation Hemodynamic Response to Noxious Stimuli in CABG Surgical Patients

NCT ID: NCT06238011

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2024-05-10

Brief Summary

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Aim to study efficacy of dexmedetomidine to attenuate hemodynamic response to intubation, skin incision, sternotomy and aortic cannulation

Detailed Description

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A randomized controlled trial was conduct between January2024 and March2024 at Sawanpracharak hospital, Thailand. Of 60 patients undergoing elective coronary artery bypass graft, 30 were assigned to group dexmedetomidine and 30 to group control. Dexmedetomidine prepared by anesthetist nurse in concentration 0.1 microgram/kg/ml total volume 50 ml. loading dose 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass (loading dose 1 microgram/kg for 10 minutes then 0.5 microgram/kg/hour). Group control receive normal saline 60ml/hour for 10minutes then 5 ml/hour

Conditions

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CABG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial was conduct between January2024 and March2024 at Sawanpracharak hospital, Thailand, Of 60 patients undergoing elective CABG surgery, 30 were assigned to group dexmedetomidine and 30 to group control. Dexmedetomidine prepared by nurse anesthetist in contraction 0.1mcg/kg/ml total volume 50 ml. Loading 60ml/hour in 10 minutes before induction of anesthesia then 5ml/hour until on cardiopulmonary bypass (1mcg/kg in 10 min then 0.5mcg/kg/hour). Group control received normal saline 60ml/hour in 10 minutes then 5ml/hour
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Dexmedetomidine

Patient in this arm will receive dexmedetomidine loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine(Precedex Pfizer) prepared in concentration 0.1 mcg/kg/ml total volume50 ml by nurse anesthetist at preprocedure room, start dexmedetomidine by anesthesiologist at operating room loading 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass (loading 1mcg/kg in 10 minutes then 0.5 mcg/kg/hour). Record patients data by nurse anesthetist

Normal Saline

Patient in this arm will receive normal saline loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary artery bypass

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal Saline total volume50 ml prepared by nurse anesthetist at preprocedure room, start Normal Saline by anesthesiologist at operating room loading 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass. Record patients data by nurse anesthetist

Interventions

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Dexmedetomidine

Dexmedetomidine(Precedex Pfizer) prepared in concentration 0.1 mcg/kg/ml total volume50 ml by nurse anesthetist at preprocedure room, start dexmedetomidine by anesthesiologist at operating room loading 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass (loading 1mcg/kg in 10 minutes then 0.5 mcg/kg/hour). Record patients data by nurse anesthetist

Intervention Type DRUG

Normal saline

Normal Saline total volume50 ml prepared by nurse anesthetist at preprocedure room, start Normal Saline by anesthesiologist at operating room loading 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass. Record patients data by nurse anesthetist

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* patients schedule for CABG
* American Society of Anesthesiologist (ASA) class II-III

Exclusion Criteria

* anticipated difficult intubation
* body mass index\> 30 kg/m2
* Ejection Fraction \< 40%
* left main coronary artery occlusion \>50%
* left bundle branch block
* severe valvular heart disease
* severe pulmonary, renal, hepatic disease
* neurologic disease
* preoperative medication with methyldopa or clonidine
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sawanpracharak hospital

OTHER

Sponsor Role lead

Responsible Party

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Padet Boonmark

Clinician at Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Padet Boonmark, MD

Role: PRINCIPAL_INVESTIGATOR

Sawanpracharak hospital Thailand

Locations

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Sawanpracharak Hospital

Nakhon Sawan, Nakhonsawan, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Padet Boonmark, MD

Role: CONTACT

+66819927577

References

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Poon WH, Ling RR, Yang IX, Luo H, Kofidis T, MacLaren G, Tham C, Teoh KLK, Ramanathan K. Dexmedetomidine for adult cardiac surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2023 Mar;78(3):371-380. doi: 10.1111/anae.15947. Epub 2022 Dec 19.

Reference Type BACKGROUND
PMID: 36535747 (View on PubMed)

Other Identifiers

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sawanpracharakhospital

Identifier Type: REGISTRY

Identifier Source: secondary_id

padetboonmark

Identifier Type: -

Identifier Source: org_study_id

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