Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery

NCT ID: NCT01524367

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-01-31

Brief Summary

Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence.

Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement.

Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.

To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children.

The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).

Conditions

Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

saline group

We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing.

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.

dexmedetomidine group

We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.

Interventions

saline

We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.

Intervention Type: DRUG

Dexmedetomidine

We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.

Intervention Type: DRUG

Other Intervention Names

normal saline; Precedex

Eligibility Criteria

Inclusion Criteria

• ASA physical status 1 or 2 patients
• patients scheduled for orthognathic surgery (two-jaw)

Exclusion Criteria

• severe cardiovascular disease
• allergy to dexmedetomidine
• psychological disease
• patients who cannot understand Korean

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yon Hee Shim

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yonhee Shim

Role: STUDY_DIRECTOR

Yonsei University

Locations

Gangnam severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2011-0200

Identifier Type: -

Identifier Source: org_study_id