Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

NCT01474213 | Completed Phase 4 Results DMC

• 1 other identifier: JYMZK-002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.

Conditions

Intubation; Difficult

Keywords

dexmedetomidine; remifentanil; awake nasotracheal fibreoptic intubation; oral maxillofacial surgery; difficult airway; adult

Outcome Measures

Primary Outcomes (2)

• Endoscopy Scores

  Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition. Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing

  during the procedure of fibreoptic and tracheal intubation

• Intubation Score

  graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing

  during the inserting of the tracheal tube

Secondary Outcomes (7)

• Patient's Reaction to Procedure

  the duration of intubation, an expected average of 10 minutes

• Post Operative Visit

  24 hours

• Mean Arterial Blood Pressure

  15 minutes before intubation, endoscopy point, intubation point

• Heart Rate

  15 minutes before intubation, endoscopy point, intubation point

• Peripheral Oxygen Saturation(SPO2)

  15 minutes before intubation, endoscopy point, intubation point

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h

Drug: dexmedetomidine group

remifentanil

ACTIVE COMPARATOR

The initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived.

Drug: remifentanil group

Interventions

dexmedetomidine group DRUG

1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine

Also known as: Dexmedetomidine Hydrochloride Injection

dexmedetomidine

remifentanil group DRUG

target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)

Also known as: Remifentanil

remifentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery

You may not qualify if:

• pregnant or lactating female,
• long-term opioids or sedative medication,
• patients \< 18 years of age,
• severe bradycardia (HR \< 50 beats/min),
• hypotension (systolic pressure \< 90mmHg),
• any type of atrioventricular block on the ECG

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (2)

Shanghai JiaoTong University, School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Limitations and Caveats

The sample number is relatively small

Results Point of Contact

• Title: Dr. Jiang Hong
• Organization: Department of Anaesthetics, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

hr310@vip.sina.com.cn

86-21-13512122883

Study Officials

• Hong Jiang, MD, PHD

  Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant in anesthesilogy department of Shanghai 9th People's Hospital

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 18, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 21, 2012
• Results First Posted: November 21, 2012

Record last verified: 2012-10

Locations

CN (2)