| CTRI Number |
CTRI/2025/03/082026 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Chlorpheniramine Maleate and Butorphanol as Premedication Intravenously on Postoperative Agitation in Adult Patients Undergoing Otorhinolaryngeal Surgery. |
|
Scientific Title of Study
|
Comparison of Effect of Intravenous Chlorpheniramine Maleate and Butorphanol as Premedication on Postoperative Agitation in Adult Patients Undergoing Otorhinolaryngeal Surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amanjot singh |
| Designation |
Professor |
| Affiliation |
GGSMCH,Faridkot |
| Address |
Department of Anaesthesia, Guru Gobind Singh Medical College and Hospital,Faridkot, 151203, India
Faridkot
PUNJAB
151203
India |
| Phone |
9814921142 |
| Fax |
|
| Email |
amanjotrajpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amanjot singh |
| Designation |
Professor |
| Affiliation |
GGSMCH,Faridkot |
| Address |
Department of Anaesthesia, Guru Gobind Singh Medical College and Hospital,Faridkot, 151203, India
Faridkot
PUNJAB
151203
India |
| Phone |
9814921142 |
| Fax |
|
| Email |
amanjotrajpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankush Bains |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh medical college and hospital,Faridkot |
| Address |
Department of Anaesthesia, GGSMCH,
Faridkot,151203, India
Faridkot
PUNJAB
151203
India |
| Phone |
7986593194 |
| Fax |
|
| Email |
ankushbains03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, GGSMCH, Faridkot, Punjab, India, 151203 |
|
|
Primary Sponsor
|
| Name |
Dr Amanjot Singh |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot, Punjab, India, 151203 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kewal Krishan Gupta |
Department of Anaesthesiology, GGSMCH, Faridkot, Punjab, India, 151203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankush Bains |
Guru Gobind Singh medical college and hospital |
Dept. Of Anaesthesiology, guru gobind singh medical college and hospital, fardikot
Faridkot
PUNJAB |
7986593194
ankushbains03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Butorphanol |
Patient will receive butorphanol 1mg diluted in 9ml isotonic saline IV 15 minute preinduction. |
| Intervention |
Chlorpheniramine |
Patients will receive chlorpheniramine maleate 5mg diluted in 9ml isotonic saline IV 15 minutes preinduction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) grade I and II. |
|
| ExclusionCriteria |
| Details |
Known allergy to chlorpheniramine maleate or/and butorphanol.
Patient with a history of neurological and psychiatric diseases.
Body mass index more than 30 of the ideal.
History of recent use of antihistaminic drugs.
Auditory or vision disorders
Pregnancy. |
|
|
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 post operative agitation in patients receiving preemptive intravenous chlorpheniramine maleate and butorphanol undergoing otorhinolaryngeal surgeries under GA. |
30 min after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the post operative agitation in patient receiving preemptive intravenous chlorpheniramine maleate undergoing Otorhinolaryngeal surgery under GA.
To assess the post operative agitation in patient receiving preemptive intravenous butorphanol undergoing Otorhinolaryngeal surgery under GA. |
30 min after surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Agitation with general anesthesia for otorhinolaryngeal surgeries was so frequent reaching up to 55.4%. Chlorpheniramine maleate a first-generation antihistaminic that antagonizes histamine H1-receptor. It is mainly used as an anti-allergic but has some anti-depressant and anti-anxiety actions, with unknown mechanism as well. Butorphanol is commonly used for the management of cancer, post-operative, gynecological, and obstetric pain. The main aim of the study is to compare the post operative agitation in patients receiving preemptive intravenous chlorpheniramine maleate and butorphanol undergoing otorhinolaryngeal surgeries under GA.The present study will be conducted in the department of Anaesthesiology, G.G.S.Medical College & Hospital, Faridkot on 80 patients belonging to ASA grade I & II, aged 18-65 years of either gender scheduled to undergo Otorhinolaryngeal surgeries. Patients will be randomly assigned into 2 equal groups. The first group (C) will receive chlorpheniramine maleate 5mg diluted in 9ml isotonic saline IV 15 minutes preinduction, second group (B) will receive butorphanol 1mg diluted in 9ml isotonic saline 15 minute preinduction. |