Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block

NCT ID: NCT05793060

Last Updated: 2026-01-12

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-12-15

Brief Summary

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

Background: Many thyroidectomy patients suffer from postoperative pain that could delay early hospital discharge and place a significant burden on both the patient and the healthcare team. Bilateral intermediate cervical plexus block (ICPB) provides good analgesia for neck surgery, including thyroidectomy. However, the duration of a single-shot nerve block is usually short. Therefore, adjuvants are used in peripheral nerve blocks.

Objectives: To compare the safety and efficacy of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided intermediate cervical plexus block in patients undergoing total thyroidectomy under general anesthesia.

Patients and Methods: This is a randomized, double-blind, phase four, prospective clinical trial; carried out on 60 patients, who were candidates for total thyroidectomy under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received bilateral ICPB with isobaric bupivacaine plus dexmedetomidine, and group B, received bilateral ICPB with isobaric bupivacaine plus dexamethasone.

Detailed Description

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

Conditions

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

Analgesia

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

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group A (n=30)

Dexmedetomidine group

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Hydrochloride

Intervention Type DRUG

Dexmedetomidine 50 Mcg

Group B (n=30)

Dexamethasone group

Group Type ACTIVE_COMPARATOR

Dexamethasone Phosphate

Intervention Type DRUG

Dexamethasone 4 mg

Interventions

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

Dexmedetomidine Hydrochloride

Dexmedetomidine 50 Mcg

Intervention Type DRUG

Dexamethasone Phosphate

Dexamethasone 4 mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Precedex Dexamethasone

Eligibility Criteria

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

Inclusion Criteria

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 60 years
* Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion Criteria

* ASA physical status \> II
* Age \< 21 years or \> 50 years
* BMI \> 35 kg/m2
* Bronchial asthma
* Chronic obstructive pulmonary disease
* Restrictive lung diseases
* Sick sinus syndrome
* Sinus bradycardia
* Hypertension
* Chronic hypotension
* Ischemic heart disease
* Coagulopathies
* Hepatic insufficiency
* Renal insufficiency
* Diabetes mellitus
* Peripheral neuropathy
* Thyroid malignancy
* Hyperthyroidism
* Substernal goiter
* Patients on beta-blockers
* Patients using pacemakers
* Alcohol or drug abuse
* Allergy to the study drugs
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

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

Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Locations

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

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Site Status RECRUITING

Countries

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

Egypt

Central Contacts

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

Ahmed M Shaat, MD

Role: CONTACT

00201223482709

Facility Contacts

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

Ahmed M Shaat, MD

Role: primary

00201223482709

Other Identifiers

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

DTH: 23001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexmedetomidine in Postoperative Analgesia
NCT05705128 ENROLLING_BY_INVITATION PHASE2/PHASE3