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

Efficacy of Dexmedetomidine for Cough Suppression During Anesthetic Emergence in Patients Undergoing Thyroid Surgery: A Randomized, Double Blinded, Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia Complication
• Intervention / Treatment: Drug: Dexmedetomidine Hydrochloride; Drug: Dexmedetomidine Hydrochloride; Drug: Dexmedetomidine Hydrochloride; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: SU Min, M.D.; Phone Number: 86-23-89011068; Email: ms89011068@163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine low dose group; 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 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; Drug: Dexmedetomidine Hydrochloride; Dexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery; Drug: Dexmedetomidine Hydrochloride; Dexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Experimental: Dexmedetomidine median dose group; 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 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; Drug: Dexmedetomidine Hydrochloride; Dexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery; Drug: Dexmedetomidine Hydrochloride; Dexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Experimental: Dexmedetomidine high dose group; 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; 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; Drug: Dexmedetomidine Hydrochloride; Dexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery; Drug: Dexmedetomidine Hydrochloride; Dexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Placebo Comparator: Control group (normal saline group); 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of coughing during anesthetic emergence	incidence of coughing within 10 minutes after extubation	within 10 minutes after endotracheal extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ccoughing on a four-point scale during anesthetic emergence	Evaluate the severity of coughing within 10 minutes after extubation by a four-point scale	within 10 minutes after endotracheal extubation
Ramsay score during anesthetic emergence	Ramsay score 1min, 5min, 10min, and 30min after extubation	within 30 minutes after endotracheal extubation
Bruggrmann comfort scale score	Bruggrmann comfort scale score 30min and 24 hrs after extubation	within 24 hrs after endotracheal extubation
VAS pain score	VAS pain score 30min, 24 hrs and 48 hrs after extubation	within 48 hrs after endotracheal extubation
Respiratory rate (RR)	Respiratory rate 1min, 5min, 10min, and 30min after extubation	within 30min after endotracheal extubation
Heart rate	Heart rate 1min, 5min, 10min, and 30min after extubation	within 30 minutes after endotracheal extubation
mean arterial pressure	Mean arterial pressure 1min, 5min, 10min, and 30min after extubation	within 30 minutes after endotracheal extubation

Collaborators and Investigators

• Sponsor: Min Su

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: dexmedetomidine; thyroid surgery; coughing during anesthetic emergence
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: CYYY2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No