Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

NCT ID: NCT03414879

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-07-25

Brief Summary

This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Detailed Description

Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB)

This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ketamine group

Nebulization with ketamine

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

While in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation..

Lidocaine group

Nebulization with with lidocaine

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

While in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation

Interventions

Ketamine

While in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation..

Intervention Type: DRUG

Lidocaine

While in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation

Intervention Type: DRUG

Other Intervention Names

Ketalar; xylocaine

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I and II of both sexes with body weight from 60-90 kg, and planned for elective awake nasal fiberoptic intubation due to expected difficulty in airway management (e.g. limited mouth opening, trismus, mandibular/ maxillary swellings or tumors, ludwig's angina, or other indications).

Exclusion Criteria

• body weight < 60 kg or > 90 kg
• uncooperative, with mental or psychological problems
• known allergy to any of the study drugs
• pregnancy
• hypertension
• cardiac disease
• liver or renal impairment
• epilepsy,
• asthmatic,
• previous bad experience of awake intubation,
• emergency operations or
• coagulation abnormalities

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Ahmad Alsayed Abdellatif

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R3/2018

Identifier Type: -

Identifier Source: org_study_id