Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

NCT03312413 | Unknown Phase 4

• 1 other identifier: CYYY2017
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Complication

Keywords

dexmedetomidine; coughing during anesthetic emergence; thyroid surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of coughing during anesthetic emergence

  incidence of coughing within 10 minutes after extubation

  within 10 minutes after endotracheal extubation

Secondary Outcomes (7)

• Ccoughing on a four-point scale during anesthetic emergence

  within 10 minutes after endotracheal extubation

• Ramsay score during anesthetic emergence

  within 30 minutes after endotracheal extubation

• Bruggrmann comfort scale score

  within 24 hrs after endotracheal extubation

• VAS pain score

  within 48 hrs after endotracheal extubation

• Respiratory rate (RR)

  within 30min after endotracheal extubation

Study Arms (4)

Dexmedetomidine low dose group

EXPERIMENTAL

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

Drug: Dexmedetomidine Hydrochloride

Dexmedetomidine median dose group

EXPERIMENTAL

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

Drug: Dexmedetomidine Hydrochloride

Dexmedetomidine high dose group

EXPERIMENTAL

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

Drug: Dexmedetomidine Hydrochloride

Control group (normal saline group)

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

Dexmedetomidine Hydrochloride DRUG

Dexmedetomidine Hydrochloride 0.2 μg·kg-1·h-will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery

Dexmedetomidine low dose group

Normal Saline DRUG

Normal saline 0.5 mL·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery

Control group (normal saline group)

Eligibility Criteria

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

You may qualify if:

• Kg/m2 ≥ BMI \> 18Kg/m2;
• undergoing general anesthesia;
• ASA physical status I and II
• undergoing elective thyroid surgery.

You may not qualify if:

• hyperthyroidism;
• preoperative bradycardia;
• liver function impairment;
• renal function impairment;
• heart function failure;
• history of asthma or COPD;
• history of diabetes;
• cognition function impairment;
• pregnant or lactating women

Sponsors & Collaborators

• Min Su: lead

Study Sites (1)

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

SU Min, M.D.

CONTACT

86-23-89011068; ms89011068@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: October 17, 2017
• Study Start: August 10, 2017
• Primary Completion: August 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)