To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laeyngoscopy and Intubation in Patients Undergoing Elective Intubation

To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laryngoscopy and Intubation in Patients Undergoung Elective Intubation

Laryngoscopy and intubation are painful stimuli ,that results in adverse physiological outcomes,like tachycrdia ,hypertension,arrythmiaa,pulmonary edema.

The main objective of study is to blunt the autonomic response of laryngoscopy and intubation.

Title of the study :To evaluate the effect of dexmedetimedine nebulization upon blunting autonomic response of laryngoscopy and intubation in patients undergoing elective intubation.

It is randomized control trial,sample size was calculated by using openEpi sample size calculator By using SBPafter 1 min of laeyngoscopy in decmedetomedine versus group were 113.2+_14.503and 125.92+_15.263 respectively,power 95 percent and confidence 95 percent ,The required sample size for the study is 72( 36 ) in each group.

After taking informed consent patients are randomly divided into two groups via opaque sealed envelop technique.Half of envelops will be labelled as letter D ,and half will be labelled as letter C .Patients in group D will be nebulized with dexmedetomedine with dose of 1ug/kg made total volume of 5 ml with normal saline.While group C will be nebulized with 5 ml of 0.9 percent normal saline 30 min prior to elective intubation.Hemodynamic parmmeters heart rate ,systolic bp,diastolic bp,MAP will be noted at baseline and 0,1,5,10 min after inrubation

Study Overview

• Status: Enrolling by invitation
• Conditions: Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laryngoscopy and Intubation in Patients Undergoing Elective Intubation
• Intervention / Treatment: Drug: Nebulization of dexmedetomedine in group D; Drug: Nebulizition with normal saline in group C,after taking informed consent patients in group cwill be nebulized with 5 ml of normal saline 30 min prior to elective intubation ,HR,SBP,DBP,MAP monitored.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Hafiza Javeria Jawed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

Age 18-65 years ASAI-III Both genders Patients undergoing elective intubation

Exclusion criteria:

Patients with renal hepatic or neurological disease Bleeding diathesis Mallampatti III-IV Previous histoey of difficult intubation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomedine nebulization in group D; Dexmedetomedine nebulization done with a dose of1ug /kg 30min prioor to induction of general anaesthesia	Drug: Nebulization of dexmedetomedine in group D; After taking informed consent ,patients are divided into 2 groups by using opaque sealed envelop technique ,half envelope were labelled with letter D ,half were labelled with letter patients in group D will be nebulized wirh dexmedetimedine wuth dose of 1ug/kgwith made total volune of 5ml by mixing with norml saline 30 min prior to intubation
Active Comparator: Normal saline nebulization in group C; Normal saline nebulization done 30min prior to induction of general anaesthesia,hemdynamic parameters heart rate,systolic bp,diastolic bp,MAP,will be noted at baseline,0,1,5,10 min after intubation	Drug: Nebulizition with normal saline in group C,after taking informed consent patients in group cwill be nebulized with 5 ml of normal saline 30 min prior to elective intubation ,HR,SBP,DBP,MAP monitored.; Groyp c will be nebulized with normal saline 30 min prior to intubation,hemodynamic parameters heart rate,systolic bp ,diastolic bp,MAP, will be monitored at baseline,0,1,5,10 min after intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
heart rate will be recorded at 0,1,5,10 min after laryngoscopy and intubation	Heart rate will be monitired at base line,0min,1min,5min,10min after intervention
SBP,DBP,MAP. measurement will be required at o ,1,5,10 min after laryngoscopy and intubation.	SBP,DBP,MAP, will be recorded at 0,1,5,10 min after laryngoscopy and intubation

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: IRB4343/DUHS/Approval/2025/479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No