Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Thyroid Neoplasm

Treatments: Drug: fentanyl citrate; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01308320

4-2009-0111

Details and patient eligibility

About

Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia.

Enrollment: 42 patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
• ASA I-II.
• 20-59 years old.
• female only.

Exclusion criteria

• signs of difficult intubation.
• risks for perioperative pulmonary aspiration.
• history of chronic respiratory disease.
• recent upper respiratory track infection.
• previous and recent smoking history

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 4 patient groups, including a placebo group

saline

Placebo Comparator group

Description:

control group

Treatment:

Drug: saline

F1 group

Active Comparator group

Description:

F1 group : fentanyl 1 mcg/kg

Treatment:

Drug: fentanyl citrate

F1.5 group

Active Comparator group

Description:

F1.5 group : fentanyl 1.5 mcg/kg

Treatment:

Drug: fentanyl citrate

F2 group

Active Comparator group

Description:

F2 group : fentanyl 2 mcg/kg

Treatment:

Drug: fentanyl citrate