NCT05657028

Brief Summary

It is widely believed that most of the patients experience a cough upon emergence from general anesthesia, due to many causes including the presence of an endotracheal tube, uncleared secretions and anesthetic gas. Cough during tracheal extubation may lead to several complications, such as hypertension, tachycardia and postoperative bleeding. In this study the investigators are going to compare the effectiveness of intravenous Dexmedetomidine and intravenous lidocaine in attenuating the air way reflexes and coughing during recovery of thyroidectomy patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

November 8, 2022

Last Update Submit

January 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • compare effectiveness of Dexmedetomidine and intravenous lidocaine in attenuating cough reflex during the tracheal extubation period after thyroid surgery

    the investigators use the following cough score where 0 = no cough, 1 = minimal (single) cough, 2 = moderate (≤5 seconds) cough and 3 = severe (\>5 seconds) cough to reflect the degree of attenuation of air way reflexes for each group

    5 minutes from extubation

Study Arms (2)

Group D (Dexmedetomidine)

EXPERIMENTAL

In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine

Drug: Dexmedetomidine

Group L (Lidocaine)

EXPERIMENTAL

In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine

Drug: Lidocaine IV

Interventions

-In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine 0.5 μg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4 μg/kg/hour until 30 min before the end of surgery.

Group D (Dexmedetomidine)

In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine (2%)1.5mg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg /hour until 30 min before the end of surgery.

Group L (Lidocaine)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective thyroidectomy surgery.
  • Age: patients between 18-and 65-years old from both sexes.
  • Classified as either American Society of Anesthesiologists (ASA) class I or II.

You may not qualify if:

  • Refusal of procedure or participation in the study.
  • Patients suffering from asthma, chronic cough, preoperative upper respiratory infection symptoms.
  • Current smoker.
  • Medication involving angiotensin-converting-enzyme inhibitors (ACE-I).
  • Classified as either American Society of Anesthesiologists (ASA) class III or IV.
  • Sinus Bradycardia (\<60/min) or history of any type of heart block or Beta-Blockers medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams University Hospitals

Cairo, 11511, Egypt

RECRUITING

Related Publications (1)

  • Hu S, Li Y, Wang S, Xu S, Ju X, Ma L. Effects of intravenous infusion of lidocaine and dexmedetomidine on inhibiting cough during the tracheal extubation period after thyroid surgery. BMC Anesthesiol. 2019 May 4;19(1):66. doi: 10.1186/s12871-019-0739-1.

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Ola N Hussain Zaher, MSC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 20, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2024

Study Completion

September 1, 2024

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations