Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03414879

Collaborator

(none)

Enrollment

Location

Arms

18.3

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Ketamine Drug: Lidocaine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study

Actual Study Start Date :

Jan 15, 2018

Actual Primary Completion Date :

Jul 25, 2019

Actual Study Completion Date :

Jul 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketamine group Nebulization with ketamine	Drug: 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.. Other Names: Ketalar
Active Comparator: Lidocaine group Nebulization with with lidocaine	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 Other Names: xylocaine

Arm

Intervention/Treatment

Active Comparator: Ketamine group

Nebulization with ketamine

Drug: 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..

Other Names:

Ketalar

Active Comparator: Lidocaine group

Nebulization with with lidocaine

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

Other Names:

xylocaine

Outcome Measures

Primary Outcome Measures

Dose of supplemental lidocaine [Intraoperative]
Dose of supplemental lidocaine during awake fiberoptic procedure

Secondary Outcome Measures

Incidence of adverse events [Intraoperative]
The incidence of adverse events related to the procedure and study drugs will be recorded
Patient satisfaction score [first 24 hours]
will be assessed against five point Likert score where (1: poor, 2: fair, 3: good, 4: very good, 5: excellent).
Patient tolerability score [Intraoperative]
Patient tolerability during the procedure will be rated as 4-point scale where 0= procedure totally intolerable with severe patient resistance (struggling/withdrawal movements). procedure partially tolerable with moderate patient resistance (restlessness/ verbal objection). procedure quiet tolerable with minimal patient resistance (just grimacing). procedure tolerable with no patient resistance. this score will be recorded at points during the intubation procedure: nasal passage, oro/hypopharynx, glottis and tube insertion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospitals	Cairo		Egypt	11591

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman Ahmad Alsayed Abdellatif, Assistant Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03414879

Other Study ID Numbers:

FMASU R3/2018

First Posted:

Jan 30, 2018

Last Update Posted:

Nov 26, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lidocaine

Ketamine

Study Results

No Results Posted as of Nov 26, 2019