Do Increasing Preoperative Timing of Single Dexmedetomidine Dose Have an Effect on Stress Response of Laryngoscopy and Intubation?

NCT07165483 | Recruiting

• 1 other identifier: 36264PR1334/8/25
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of increasing preoperative timing of single dexmedetomidine on the stress response of laryngoscopy and intubation.

Conditions

Time; Dexmedetomidine; Stress Response; Laryngoscopy; Intubation

Outcome Measures

Primary Outcomes (1)

• Mean arterial pressure

  Mean arterial pressure will be recorded at baseline, before induction, after induction, before intubation, after intubation, at 5 minutes, 10 minutes, 15 minutes, and then every 15 minutes until the end of surgery.

  Till the end of the surgery (Up to 2 hours)

Secondary Outcomes (3)

• Heart rate

  Till the end of the surgery (Up to 2 hours)

• Need for intraoperative fentanyl

  Intraoperatively

• Incidence of adverse events

  24 hours postoperatively

Study Arms (3)

Group D20

EXPERIMENTAL

Patients will receive 0.5µg/kg dexmedetomidine (over 10 min) 20 min before induction of anesthesia then saline (over 10 min) 10 min before induction of anesthesia.

Drug: Dexmedetomidine

Group D10

EXPERIMENTAL

Patients will receive saline (over 10 min) 20 min before induction of anesthesia then 0.5µg/kg dexmedetomidine (over 10 min) 10 min before induction of anesthesia.

Drug: Dexmedetomidine

Group C

PLACEBO COMPARATOR

Patients will receive saline before induction of anesthesia as a control group.

Drug: Saline

Interventions

Dexmedetomidine DRUG

Patients will receive 0.5µg/kg dexmedetomidine (over 10 min) 20 min before induction of anesthesia then saline (over 10 min) 10 min before induction of anesthesia.

Group D20

Saline DRUG

Patients will receive saline before induction of anesthesia as a control group.

Group C

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.

You may not qualify if:

• Severe cardiovascular problems.
• Respiratory disorders.
• Diabetes.
• Hypertension.
• Obesity.
• Allergic reaction to study drugs.
• Patients on antihypertensive medication (α-methyldopa, clonidine, or other α2-adrenergic agonists)
• Medications that affect heart rate (HR) or blood pressure (BP).
• Pregnant.
• Currently breast-feeding women.
• History of sleep apnea.
• Those for emergency procedures.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 11, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)