CTRI

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CTRI Number

CTRI/2023/09/057764 [Registered on: 18/09/2023] Trial Registered Prospectively

Last Modified On:

15/09/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Post operative dexmedetomidine nebulization for post operative pain management

Scientific Title of Study

Post operative dexmedetomidine nebulization as an analgesic adjunct in post operative pain management: A randomised controlled trial in laparoscopic cholecystectomy patients

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	DEEPAK HANSDAH
Designation	JUNIOR RESIDENT
Affiliation	RAJENDRA INSTITUTE OF MEDICAL SCIENCES
Address	DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI, BARIATU Ranchi JHARKHAND 834009 India
Phone	9931111738
Fax
Email	deep1738@gmail.com

Details of Contact Person
Scientific Query

Name	DR LADHU LAKRA
Designation	HEAD OF DEPARTMENT (ANAESTHESIOLOGY)
Affiliation	RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI
Address	DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI, BARIATU Ranchi JHARKHAND 834009 India
Phone	9835160608
Fax
Email	dr.ladhulakra007@gmail.com

Details of Contact Person
Public Query

Name	DEEPAK HANSDAH
Designation	JUNIOR RESIDENT
Affiliation	RAJENDRA INSTITUTE OF MEDICAL SCIENCES
Address	DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI, BARIATU Ranchi JHARKHAND 834009 India
Phone	9931111738
Fax
Email	deep1738@gmail.com

Source of Monetary or Material Support

RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI, PIN-834009, JHARKHAND

Primary Sponsor

Name	DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES
Address	DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR DEEPAK HANSDAH	RAJENDRA INSTITUTE OF MEDICAL SCIENCES	DEPARTMENT OF ANAESTHESIOLOGY Ranchi JHARKHAND	09931111738 deep1738@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE, RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K80\|\|Cholelithiasis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Control group recieve normal saline nebulization	Group B recieve normal saline nebulization, and monitored for 24 hours
Intervention	Post operative dexmedetomidine nebulization for pain management	Group A recieve dexmedetomidine nebulization at a concentration of 2 mcg/kg body weight, and monitored for 24 hours

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	ASA Physical status I and II. Weight of 45 to 90 kg. Height of 150 to 180 cms. Patients undergoing elective laparoscopic cholecystectomy surgery.

ExclusionCriteria

Details

ASA Physical status III and IV.
Patient unwilling.
Haemodynamically unstable patients.
Duration of surgery exceeding more than 2 hour.
History of any allergy to general anaesthetic agents.
Significant history of drug/alcohol abuse.
Patients with comorbidities (hypertension, diabetes).

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
To compare the pain scores (NRS) in both group To compare the total dose of rescue analgesia used in both groups.	To compare the pain scores (NRS) in both group within 24 hours, namely at 15 mins, 30 mins, 1 hr, 2 hr, 6 hr, 12 hr, 24 hr. To compare the total dose of rescue analgesia used in both groups, within 24 hours.

Secondary Outcome

Outcome	TimePoints
Sedation score (Ramsay) in both the group Incidence of delirium in both the group Post operative sore throat in both the group	24 hour

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

30/09/2023

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This study is a randomised controlled trial, double blind study, checking the efficacy of post operative nebulization of Dexmedetomidine as an analgesic adjunct in a patients of laparoscopic cholecytectomy.

Patients are divided into 2 groups. Group A patients are nebulized with dexmedetomidine with the dose of 2mcg/kg (total of 5 ml). Group B patients are nebulized with 5 ml of normal saline.

Our primary objective is to compare the pain score (NRS) at 15, 30 mins, 1, 2, 6, 12, 24 hr and total dose of rescue Analgesia (Tramadol) used in both groups in first 24 hour. Secondary objective is to compare sedation score (Ramsay), incidence of delirium and post operative sore throat in both the groups.

Inclusion criteria include ASA Physical status I and II, 18 to 65 years of either sex, Weight of 45 to 90 kg, Height of 150 to 180cms and Patients undergoing elective laparoscopic cholecystectomy surgery.

Exclusion criteria include ASA Physical status III and IV, Patient unwilling, Haemodynamically unstable patients, Duration of surgery exceeding more than 2 hour, History of any allergy to general anesthetic agents, Significant history of drug/alcohol abuse, Patients with comorbidities (hypertension, diabetes), conversion of laproscopic cholecytectomy to open cholecytectomy.