Nebulized Lidocaine, Dexmedetomedine and Their Combination in Direct Laryngoscopy Surgery

NCT04659057 | Completed Phase 4

• 1 other identifier: FMASU R 110/2020
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

Direct laryngoscopy (DL) procedure is typically done under general anaesthesia as a day case. It is a short but irritating.Various drugs and drug combinations have been used to attenuate stress response to DL.Administrating nebulized form of drugs can be effective with less systemic side effects. The primary outcome of this study is to compare the effect of premedication with nebulized lidocaine, dexmedetomidine, combination of both to placebo on haemodynamic response during DL procedures.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (4)

• Heart Rate

  Heart rate in beats/min

  Every 5 minutes for 30-60minutes

• Systolic blood pressure

  Systolic blood pressure in mmHg

  Every 5 minutes for 30-60 minutes

• Diastolic blood pressure

  Diastolic blood pressure in mmHg

  Every 5 minutes for 30-60 minutes

• Mean arterial pressure

  Mean arterial pressure in mmHg

  Every 5 min for 30-60 minutes

Secondary Outcomes (2)

• Total fentanyl and esmolol consumption

  For 30-60 minutes

• recovery time

  5- 15 minutes

Study Arms (4)

Group L

ACTIVE COMPARATOR

Lidocaine group; 45 randomly assigned patients.

Drug: Nebulized Lidocaine

Group D

ACTIVE COMPARATOR

Demedetomidine group; 45 randomly assigned patients.

Drug: Nebulized dexmedetomidine

Group DL

ACTIVE COMPARATOR

Combined lidocaine and dexmedetomidine group. 45 randomly assigned patients.

Drug: Nebulized lidocaine and dexmedetomidine

Group C

PLACEBO COMPARATOR

Control group; 45 randomly assigned patients.

Other: Placebo

Interventions

Nebulized Lidocaine DRUG

will receive nebulized lidocaine 2%, 1 mg/kg with a maximum dose of 100 mg (5 ml).

Also known as: Lidocaine group

Group L

Nebulized dexmedetomidine DRUG

will receive nebulized dexmedetomidine (1 μg/kg diluted in 5 ml of saline 0.9%).

Also known as: Dexmedetomidine group

Group D

Nebulized lidocaine and dexmedetomidine DRUG

will receive nebulized lidocaine 2% (0.5 mg/kg) and dexmedetomidine 0.5 μg/kg dexmedetomidine in 5 ml of saline 0.9%.

Also known as: Combined lidocaine and dexmedetomidine group

Group DL

Placebo OTHER

will receive nebulized saline 0.9% (5 ml) as control group.

Also known as: Control group

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III patients admitted for DL surgery.

You may not qualify if:

• Uncontrolled hypertension (MAP \> 100 mmHg) or ischaemic heart disease.
• End stage renal impairment.
• Chronic drug or alcohol abuse.
• Predicted difficult airway, laryngoscopy and intubation time \> 30 sec, more than one attempt of intubation.
• Morbid obesity (BMI \> 30).
• Known allergy to the drugs used.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location

Ain Shams University Hospitals

Cairo, 11588, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Control Groups

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hala S El-Ozairy, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anaesthesia, ICU and Pain management, Faculty of Medicine, Ain Shams University

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 9, 2020
• Study Start: December 12, 2020
• Primary Completion: July 11, 2021
• Study Completion: July 11, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

EG (2)