Preoperative Topical Lidocaine Versus Intravenous Fentanyl to Obtund the Stress of Intubation Under Anesthesia.

NCT07533643 | Completed DMC

• 1 other identifier: MS-300-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of preoperative combined topical airway anesthesia consisting of nebulised, mouth rinsing and gargling with lidocaine versus intravenous fentanyl to prevent the stress of endotracheal intubation by direct laryngoscopy under general anesthesia.

Conditions

Hemodynamics After Endotracheal Intubation

Keywords

stress of intubation; Intubation , endotracheal; laryngoscopy; fentanyl; lidocaine

Outcome Measures

Primary Outcomes (1)

• Maximum change in systolic blood pressure 5 minutes after endotracheal intubation from the baseline in both groups.

  Automated non-invasive blood pressure monitor was used.

  within 5 minutes post-intubation

Study Arms (2)

Topical lidocaine

EXPERIMENTAL

nebulized lidocaine + mouth rinse + gargling dose 4.5mg per kg given pre-operatively drug topical lidocaine 2% topical lidocaine nebulized for 10 min + mouth rinsing and gargling for 3 min

Drug: topical lidocaine

iv fentanyl

ACTIVE COMPARATOR

iv fentanyl dose 1 microgram per kg just before induction drug :Fentanyl citrate (0.05 mg/ml) (Fentanyl Hameln pharmaceutical, Germany) (Low Dose) low dose fentanyl iv 1 microgram per kg before induction

Drug: Fentanyl (Low Dose)

Interventions

topical lidocaine DRUG

topical lidocaine nebulized for 10 min + mouth rinsing and gargling for 3 min

Topical lidocaine

Fentanyl (Low Dose) DRUG

low dose fentanyl iv 1 mic per kg before induction

iv fentanyl

Eligibility Criteria

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

You may qualify if:

• American society of anaesthesiologists class 1 or 2 (ASA 1 or 2) patients.
• Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation using direct laryngoscope.
• Population aged from 18 to 60 years.

You may not qualify if:

• Patient's refusal to participate.
• ASA class 3 or more patients including Substantive functional limitations; One or more moderate to severe diseases. Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, history of MI, CVA, TIA, or CAD/stents, asthma with exacerbation, poorly controlled epilepsy.
• Patients with any degree of Hypertension or treated for hypertension.
• Pregnant patients.
• Age of participant less than 18 or more than 60 years.
• History of allergy to local anaesthetics or opioids.
• Opioid abuse
• Anticipated difficult airway which will be defined as El-Ganzouri Risk Index (EGRI) score of 4 or more points.
• Difficult intubation which will be defined as situation where proper insertion of the tracheal tube with conventional laryngoscopy requires more than three attempts or more than 10 min.
• Difficult mask ventilation which will be defined as a situation that develops when it is not possible for the unassisted anaesthesiologist to maintain the oxygen saturation \>90% using 100% oxygen and positive pressure ventilation, or to prevent or reverse signs of inadequate ventilation.
• Patients requiring more than one attempt of intubation.
• Intubation time more than 30 seconds.
• Emergency surgeries or patients requiring rapid sequence induction for other reasons.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Medical School

Cairo, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Fentanyl

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed Ahmed Mansour, professor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Shady Rady Abdalla, lecturer

  Cairo University

  STUDY DIRECTOR

• sherif Ismail Muhammed, lecturer

  Cairo University

  STUDY DIRECTOR

• Zeinab Mohammed Gamal, Resident

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residents

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: August 1, 2025
• Primary Completion: September 20, 2025
• Study Completion: November 15, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

EG (1)