Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia

NCT02613806 | Unknown Phase 4

• 1 other identifier: CYYYMZK-08
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative bleeding.Postoperative bleeding is a serious and potentially life-threatening complication，which could result in acute upper airway obstruction due to neck hematoma and increase the need for re-operation.The purpose of this study is to investigate whether dexmedetomidine can reduce the incidence of postoperative coughing and contribute to postoperative recovery in patients undergoing tyroid surgery with general anesthesia.

Conditions

Coughing Response; Thyroid Surgery; General Anesthesia

Keywords

Dexmedetomidine; Coughing Response; Postoperative Recovery Quality; Thyroid Surgery

Outcome Measures

Primary Outcomes (1)

• the incidence of coughing

  coughing will be observed

  within 48 hours postoperatively

Secondary Outcomes (5)

• coughing on a four-point scale

  within 48 hours postoperatively

• the eyes opening time

  within 48 hours postoperatively

• the time of extubation

  within 48 hours postoperatively

• visual analogue scale (VAS)

  at 30 minutes after extubation

• sedation-agitation scale(SAS)

  at 30 minutes after extubation

Study Arms (2)

D group (dexmedetomidine)

EXPERIMENTAL

Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion with microperfusion pump at the beginning of the surgery,and continued till end of surgery.

Drug: Dexmeditomidine

C group (saline)

ACTIVE COMPARATOR

The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery.

Drug: normal saline

Interventions

Dexmeditomidine DRUG

Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.

D group (dexmedetomidine)

normal saline DRUG

Isovolumetric normal saline will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.

C group (saline)

Eligibility Criteria

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

You may qualify if:

• Aged from 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical statusⅠor Ⅱ
• Diagnosed by B ultrasonic or tissue biopsy show that patients thyrophyma,thyroid cancer,thyroid nodule,etc,who need to accept thyroid surgery

You may not qualify if:

• large goiter or hyperthyroidism
• Preoperative coughing caused by primary diseases of patients
• Ⅱdegrees above atrioventricular block
• Allergy to anesthesia
• History of diabetes
• Pregnant women
• Serious mental disease
• History of alcohol or drug abuse
• Severe heart renal or liver dysfunction
• The presence of an upper respiratory infection
• Asthma
• Anticipated difficult airway

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (6)

• Bergese SD, Khabiri B, Roberts WD, Howie MB, McSweeney TD, Gerhardt MA. Dexmedetomidine for conscious sedation in difficult awake fiberoptic intubation cases. J Clin Anesth. 2007 Mar;19(2):141-4. doi: 10.1016/j.jclinane.2006.07.005.

  PMID: 17379129 BACKGROUND

• Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.

  PMID: 20039221 BACKGROUND

• Kiray A, Naderi S, Ergur I, Korman E. Surgical anatomy of the internal branch of the superior laryngeal nerve. Eur Spine J. 2006 Sep;15(9):1320-5. doi: 10.1007/s00586-005-0006-7. Epub 2006 Jan 5.

  PMID: 16402208 BACKGROUND

• Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.

  PMID: 11046225 BACKGROUND

• Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.

  PMID: 22824921 BACKGROUND

• Ham SY, Kim JE, Park C, Shin MJ, Shim YH. Dexmedetomidine does not reduce emergence agitation in adults following orthognathic surgery. Acta Anaesthesiol Scand. 2014 Sep;58(8):955-60. doi: 10.1111/aas.12379.

  PMID: 25132201 BACKGROUND

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Su Min

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanping Zhang, Master

CONTACT

023-89011061; 398254227@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Department of Anesthesia and Pain Medicine

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

CN (1)