Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery (EDCSTS)

Min Su

Status and phase: Unknown; Phase 4

Conditions: Anesthesia Complication

Treatments: Drug: Dexmedetomidine Hydrochloride; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03312413

CYYY2017

Details and patient eligibility

About

Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery.

American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 30Kg/m2 ≥ BMI > 18Kg/m2;
2. undergoing general anesthesia;
3. ASA physical status I and II
4. undergoing elective thyroid surgery.

Exclusion criteria

1. hyperthyroidism;
2. preoperative bradycardia;
3. liver function impairment;
4. renal function impairment;
5. heart function failure;
6. history of asthma or COPD;
7. history of diabetes;
8. cognition function impairment;
9. pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups, including a placebo group

Dexmedetomidine low dose group

Experimental group

Description:

Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.2μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery

Treatment:

Drug: Dexmedetomidine Hydrochloride

Drug: Dexmedetomidine Hydrochloride

Drug: Dexmedetomidine Hydrochloride

Dexmedetomidine median dose group

Experimental group

Description:

Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.5μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery

Treatment:

Drug: Dexmedetomidine Hydrochloride

Drug: Dexmedetomidine Hydrochloride

Drug: Dexmedetomidine Hydrochloride

Dexmedetomidine high dose group

Experimental group

Description:

Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.7μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery

Treatment:

Drug: Dexmedetomidine Hydrochloride

Drug: Dexmedetomidine Hydrochloride

Drug: Dexmedetomidine Hydrochloride

Control group (normal saline group)

Placebo Comparator group

Description:

Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery

Treatment:

Drug: Normal Saline