Role of Nebulized Dexmedetomidine in Blunting the Effects of Direct Laryngoscopy and Endotracheal Tube on Heart Rate and Blood Pressure.

NCT06103721 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: No.F.3-1/2023(ERRB)/Chairman
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to check the effectiveness of nebulized Dexmedetomidine in preventing the rise in blood pressure and heart rate in patients undergoing General Anesthesia. The study will be conducted in patients presenting for elective surgery either healthy or having co-existing medical conditions which affect their daily living to a moderate extent. These participants will require general anesthesia for their surgical procedure. General Anesthesia will make the patient unconscious, unable to breath and protect his airway. One way to provide airway and ventilatory support to such patient is by placing endotracheal tube into the patient's windpipe and for that direct laryngoscopy is performed. Direct laryngoscopy is one of the most painful stimulus a person can receive. Therefore like any other thing that causes pain it leads to a rise in blood pressure and heart rate. This can be harmful to the person suffering from cardiac disease. As a result one must blunt this painful response while providing adequate airway support to the patient needing General Anesthesia. There are number of drugs which can be used for this purpose. They can be given Intravenously or directly into the patient upper airway so that they can make the area numb. One of the drugs which is used for this purpose is Dexmedetomidine. In this study Dexmedetomidine will be nebulized and directly deliver to the patient's airway just like an asthmatic receives medication from inhaler devices. After giving sufficient time for drug to work, airway will be secured with endotracheal tube using direct laryngoscopy and the degree of rise in Blood Pressure and Heart rate of the patient will be observed. The results will be compared with a control group receiving a substance which looks like a drug but has no effects.

Conditions

Hemodynamic Instability

Keywords

Dexmedetomidine; Stress response to laryngoscopy; General Anaesthesia; Direct Laryngoscopy

Outcome Measures

Primary Outcomes (2)

• Heart Rate

  Heart Rate is measured as a part of standard ASA monitoring through electronic cardiac monitor showing electrocardiogram as well as heart rate (no. of beats/min).

  Heart Rate will be assessed pre-nebulization, pre-induction, and at 1 minute intervals during bag mask ventilation, and immediately after endotracheal tube placement.

• Blood Pressure

  Blood pressure including Systolic, Diastolic and Mean arterial pressure is measured as a part of standard ASA monitoring. This is measured in units of mm of Hg through automated Non-invasive Blood pressure monitoring device.

  Systolic, Diastolic and Mean arterial blood pressure will be assessed pre-nebulization, pre-induction, and at 1 minute intervals during bag mask ventilation, and immediately after endotracheal tube placement.

Study Arms (2)

Group Dexmedetomidine

EXPERIMENTAL

This will be the intervention group. Patients entering this group through computer generated random numbers will receive nebulization Dexmedetomidine in the pre-operative area under the supervision of consultant anesthetist.

Drug: Dexmedetomidine Injection [Precedex]

Group Normal Saline

PLACEBO COMPARATOR

This will be the placebo or control group. Patients entering this group through computer generated random numbers will receive nebulization with Normal Saline (placebo) in the pre-operative area under the supervision of consultant anesthetist.

Drug: Normal Saline

Interventions

Dexmedetomidine Injection [Precedex] DRUG

Dexmedetomidine will be diluted in 20 ml of Normal Saline to produce a concentration of 20 mcg/ml. Then it will be taken from the dilution at a dose of 1.0 mcg/kg and that will be added in 2-3 ml of Normal Saline to make it a final volume of 10ml. The resultant mixture will be used to nebulize the patients for 5 minutes, 15 minutes prior to induction of General Anesthesia. Then general anesthesia will be induced with 1mg of Midazolam, 2mg/kg of Propofol, 0.5 mg/kg of Atracurium. Prior to endotracheal tube placement, airway will be managed with bag mask ventilation for 3 minutes. Vitals will be measured pre-nebulization, pre-induction, at 1 minute intervals during bag mask ventilation and immediately after placement of endotracheal tube.

Also known as: Intervention

Group Dexmedetomidine

Normal Saline DRUG

Patients in the placebo group will be nebulized with 10 ml of Normal Saline, 15 minutes prior to induction of general anesthesia. Then general anesthesia will be induced with 1mg of Midazolam, 2mg/kg of Propofol, 0.5 mg/kg of Atracurium. Prior to endotracheal tube placement, airway will be managed with bag mask ventilation for 3 minutes. Vitals will be measured pre-nebulization, pre-induction, at 1 minute intervals during bag mask ventilation and immediately after placement of endotracheal tube.

Also known as: Placebo

Group Normal Saline

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 16 years and above.
• American Society of Anesthesiologists (ASA) class: I, II and III.
• Elective surgeries under General Endotracheal Anesthesia.
• Potentially difficult airway.

You may not qualify if:

• Pregnancy
• Body mass index \>35 kg/m2
• Known allergy to drugs used in the study
• Liver and renal insufficiency

Sponsors & Collaborators

• Muhammad Haroon Anwar: lead
• Pakistan Institute of Medical Sciences: collaborator

Study Sites (1)

Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (1)

• Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20.

  PMID: 32434291 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Methods; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Muhammad Haroon Anwar, MBBS

  Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Haroon Anwar, MBBS

CONTACT

+92-333-5236956; haroonanwar22@gmail.com

Naheed Fatima, MBBS,FCPS

CONTACT

+92-300-5236655; naheedfk73@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Anaesthesia and Critical Care Medicine

Model Details: Patients fulfilling the inclusion criteria will be enrolled and divided into two groups through computer generated random numbers. Intervention will be done in the preoperative area under supervision of consultant anesthetist. Afterwards patient will be shifted to operating room, standard ASA monitoring will be attached. General anesthesia will be induced with 1mg of midazolam, 2mg/kg of propofol and 0.5 mg/kg of atracurium. Patient will then be bag mask ventilated for 3 minutes using 100% oxygen at 5 L/min along with Sevoflurane at a MAC (Minimum alveolar concentration) of 1. Vitals will be measured pre-nebulization, pre-induction, and at 1-minute intervals during bag mask ventilation and finally immediately after endotracheal tube placement. Failure to blunt hemodynamic response will be defined as rise in heart rate or blood pressure by more than 20% from pre-induction values immediately after laryngoscopy and endotracheal tube placement which will be managed accordingly.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 27, 2023
• Study Start: November 21, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)