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

NCT ID: NCT02613806

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Thyroid surgery is a common clinical surgery,the incidence of postoperative coughing is up to 32.4%.Coughing response could result in postoperative bleeding,even cause respiratory tract obstruction,affect patients' postoperative recovery .Dexmedetomidine,an α2 adrenergic agonist,has hypnotic,analgesic, anxiolytic,antisympathetic effects,which could facilitate the sedation of patients while maintaining their consciousness and keep respiration and circulation stable .For these benefits,dexmedetomidine was widely used for general anesthesia.However,whether dexmedetomidine can reduce the incidence of postoperative coughing is unclear.Therefore,the investigators conduct this randomized controlled double-blind trial,to investigate the effects of dexmedetomidine on coughing and postoperative recovery quality in patients undergoing tyroid surgery with general anesthesia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coughing Response Thyroid Surgery General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

D group (dexmedetomidine)

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.

Group Type EXPERIMENTAL

Dexmeditomidine

Intervention Type 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.

C group (saline)

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

Group Type ACTIVE_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmeditomidine

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.

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. large goiter or hyperthyroidism
2. Preoperative coughing caused by primary diseases of patients
3. Ⅱdegrees above atrioventricular block
4. Allergy to anesthesia
5. History of diabetes
6. Pregnant women
7. Serious mental disease
8. History of alcohol or drug abuse
9. Severe heart renal or liver dysfunction
10. The presence of an upper respiratory infection
11. Asthma
12. Anticipated difficult airway
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Min Su

The Department of Anesthesia and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Su Min

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yanping Zhang, Master

Role: CONTACT

023-89011061

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Su Min, MD.

Role: primary

+86-23-89011068

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17379129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20039221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16402208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11046225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22824921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25132201 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CYYYMZK-08

Identifier Type: -

Identifier Source: org_study_id