Safety and Efficacy of Dexmedetomidine in Controlling Hemodynamics During Resection of Active Thyroid Secreting Tumors

NCT07434206 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 18- 2024-685
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Experienced anesthesiologists often attempt to anticipate and blunt the hypertensive responses seen in varying degrees at critical moments of surgical stimulation. Additionally, it may take a long time to treat acute intraoperative hypertension using anesthetics, and there may be a subsequent period of hypotension due to over-compensation. Most practicing anesthesiologists rely on antihypertensive drugs for the rapid control of elevated arterial blood pressure, when volatile anesthetics and narcotics need to be discontinued for awakening. Relatively high doses of antihypertensive drugs, such as labetalol, nicardipine, or esmolol, are commonly used, regardless of the anesthetic technique.One of the main methods to control arterial blood pressure intraoperatively, was to use a typical antihypertensive regimen on an as-needed basis as well as common methods; adjustments in the concentration of volatile anesthetic.

Conditions

Thyroid Neoplasms

Outcome Measures

Primary Outcomes (2)

• Intraoperative hemodynamics

  mean blood pressure values

  5 hours intraoperatively

• Intraoperative hemodynamics

  heart rate values

  5 hours intraoperatively

Secondary Outcomes (2)

• Intensity of pain

  24 hours postoperatively

• Sedation:

  24 hours postoperatively

Study Arms (2)

labetalol Group (Control group)

ACTIVE COMPARATOR

where patients will receive an initial bolus dose of labetalol 20 mg by slow IV injection over a 2-minute period before surgical incision to achieve target hemodynamics. Additional injections of 40 to 80 mg can be given on demand at 10-minute intervals until a desired supine blood pressure is achieved or a total of 300 mg has been used then continuous infusion of diluted labetalol solution will be administered at a rate of 2 mL/min to deliver 2 mg/min to control BP swings intraoperatively.

Drug: Dexmedetomidine Injection [Precedex]

Dexmedetomidine group (Active Group);

ACTIVE COMPARATOR

where patients will receive an iv-bolus dose of 0.5-1 μg/kg of dexmedetomidine over 10 min before surgical incision followed by IV infusion of 0.2 - 0.7 μg/kg/h to control BP intraoperatively.

Drug: Dexmedetomidine Injection [Precedex]

Interventions

Dexmedetomidine Injection [Precedex] DRUG

The study medications as dexmedetomidine and labetalol was prepared by an anesthesia assistant not involved in the study. A 50 ml syringe was filled with 50 μg dexmedetomidine diluted in normal saline solution in Dexmedetomidine group, while, 1 ml labetalol (50 mg) diluted in N.S solution in a 50 ml syringe for infusion in labetalol group was prepared.

Also known as: precedex infusion group

Dexmedetomidine group (Active Group);; labetalol Group (Control group)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients subjected to thyroid resection surgeries for active thyroid tumors.
• The enrolled age will be from 20 years to 65 years
• ASA, I-III and NYHA, I-II.

You may not qualify if:

• ASA physical status \>III and NYHA \>II,
• body mass index \>40 kg/m2,
• pregnant women,
• preoperative opioid consumption,
• Allergy to dexmedetomidine
• Contraindications as hypotension or cardiovascular compromise
• Unwilling to participate in the study

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

south Egypt cancer institute

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• mohammed fa abd el hamed, lecturer

  lecturer of anaesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia and icu

Model Details: Consented patients were allocated into one of two anesthetic groups: labetalol group or Dexmedetomidine group after being assessed for inclusion and exclusion criteria.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: February 25, 2026
• Study Start: April 25, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)