Dexmedetomidine Versus Ketamine-midazolam Sedation in Awake Fiberoptic Intubation in Suspected Difficult Airway

NCT06946212 | Completed Phase 4

• 1 other identifier: Zu-IRB 10831-28/5-2023
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to obtain the optimal patient's comfort and cooperation during awake fiberoptic intubation with prototype device. The main question it aims to answer is: Which drug provides better sedative effect during awake fiberoptic intubation, dexmedetomidine or ketamine- midazolam combination with prototype supraglottic topical anaesthesia device?

Conditions

Awake Fiberoptic Intubation

Keywords

Sedation; Awake fiberoptic intubation

Outcome Measures

Primary Outcomes (1)

• Patient tolerance

  Patient tolerance assessed by independent observer by a five-point fiberoptic intubation comfort score (1 = no reaction, 2 = slight grimacing, 3 = heavy grimacing, 4 = verbal objection, 5 = defensive movement of head and hands

  During the procedure of awake fiberoptic intubation

Secondary Outcomes (1)

• Intubation score

  During the procedure of awake fiberoptic intubation

Other Outcomes (4)

• Intubation time

  from introduction of fibroscope till endotracheal tube in place confirmed.

• Mean arterial blood pressure

  at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation

• Heart rate

  Heart rate assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation

Study Arms (2)

dexmedetomidine group

ACTIVE COMPARATOR

patients will receive an intravenous dose of dexmedetomidine at 1 mcg/kg over 10 min in 100 mL normal saline followed by continous infusion of dexmedetomidine at 0.2mcg/kg/h up to 0.7mcg/kg/hr till reaching Ramsay sedation score 2-3

Drug: Dexmedetomidine

ketamine with midazolam Group

ACTIVE COMPARATOR

patients will receive midazolam 0.02 mg /kg IV then 2 minutes later take ketamine 0.25 mg/kg IV and we will repeated this mixture till reaching Ramsay sedation score 2-3

Drug: Ketamine plus Midazolam

Interventions

Dexmedetomidine DRUG

In Dexmedetomidine group: patients received an intravenous dose of dexmedetomidine at 1 mcg/kg over 10 min in 100 mL normal saline followed by continous infusion of dexmedetomidine at 0.2mcg/kg/h up to 0.7mcg/kg/hr till reaching Ramsay sedation score 2-3

dexmedetomidine group

Ketamine plus Midazolam DRUG

In Ketamine Midazolam group: patients received midazolam 0.02 mg /kg IV then 2 minutes later take ketamine 0.25 mg/kg IV and we will repeated this mixture till reaching Ramsay sedation score 2-3

ketamine with midazolam Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient consent
• Age 21 to 60 years
• Both male and female
• ASA I and ASA II
• BMI : ((18.5 - 35 kg/ m2 )),
• Patient scheduled to undergo elective surgeries under general anesthesia.
• Patient with suspected difficult airway.

You may not qualify if:

• Sever chronic disease (cardiovascular, respiratory, renal and hepatic).
• Coagulopathies
• Mental retarted or psychiatric disorder.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Ketamine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 27, 2025
• Study Start: May 15, 2023
• Primary Completion: January 20, 2024
• Study Completion: April 4, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)