| CTRI Number |
CTRI/2024/03/063761 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of drugs Dexmedetomidine and Pentazocine-promethazine in patients undergoing tympanoplasty under sedation |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine versus Pentazocine-Promethazine for Tympanoplasty under Monitored Anesthesia Care: Randomized Double Blind study |
| 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.Swetha Yadavalli |
| Designation |
Postgraduate junior resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
A BLOCK OT COMPLEX,4TH FLOOR, A BLOCK,HOSPITAL BUILDING,All India Institute of Medical Sciences, TATIBANDH, RAIPUR,CHHATTISGARH, 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8072469443 |
| Fax |
|
| Email |
swetha.yadavalli99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NandKishore Agrawal |
| Designation |
Professor and Head of Department of Anesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
A block OT COMPLEX,4TH FLOOR, A BLOCK, HOSPITAL BUILDING,All India Institute of Medical Sciences, TATIBANDH, RAIPUR,CHHATTISGARH, 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9373103294 |
| Fax |
|
| Email |
nkagarwal1963@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swetha Yadavalli |
| Designation |
Postgraduate junior resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
A BLOCK OT COMPLEX,4TH FLOOR, A BLOCK,HOSPITAL BUILDING,All India Institute of Medical Sciences, TATIBANDH, RAIPUR,CHHATTISGARH, 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8072469443 |
| Fax |
|
| Email |
swetha.yadavalli99@gmail.com |
|
|
Source of Monetary or Material Support
|
| All IndiaInstituteofMedicalSciences, Raipur(all drugs that are used are available in routine Ot drug supply) |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Raipur |
| Address |
All India Institute of Medical Sciences, Raipur
Great eastern road, opposite gurudwara,TATIBANDH, RAIPUR, CHHATTISGARH 492099 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSwetha yadavalli |
All India Institute of Medical Sciences, Raipur |
Operation theatre-HEAD AND NECK SURGERY(4),A BLOCK OT COMPLEX,4th FLOOR, A BLOCK, HOSPITAL BUILDING,All India Institute of Medical Sciences, Raipur
Great eastern road, opposite gurudwara,TATIBANDH, RAIPUR, CHHATTISGARH 492099
Raipur
CHHATTISGARH |
8072469443
swetha.yadavalli99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine In tympanoplasty under Monitored anaesthesia care |
One group will receive inj. Dexmedetomidine 1mcg/kg in 10ml NS (normal saline ) over 10 minutes IV followed by it’s infusion at a rate of 0.2 mcg/kg/hr through infusion pump, until 15 minutes prior to surgical closure
|
| Comparator Agent |
Pentazocine-Promethazine in tympanoplasty under Monitored anaesthesia care |
One group will receive a dose of inj.Pentazocine 0.6mg/kg and inj. Promethazine 0.5mg/kg IV in 10 ml NS mixed together and given over 10minutes followed by infusion of 0.2 mcg/kg/hr of NS through infusion pump,until 15 minutes prior to surgical closure
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with chronic otitis media mucosal type posted for tympanoplasty.
2.Patients who have given consent for study.
3.Patients of ASA-PS I- II
4.Patients in the age group of 18-65 years of either sex.
|
|
| ExclusionCriteria |
| Details |
1.Patients undergoing mastiodectomy
2.Patients who are not willing for consent.
3.Patients of ASA-PS III, IV
4.Patients with known allergic history to local anaesthetics, dexmedetomidine, pentazocine and promethazine.
5.Patients with uncontrolled psychiatric illness.
Pregnancy.
6.Patients with history of seizure disorder,neuroleptic malignant syndrome, heart failure,renal or liver failure.
7.Special group of population protected by the law and requires additional permission beyond the participant’s consent.
|
|
|
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 |
Primary : To compare the pain and sedation among the groups.
|
Upto 4 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare recovery and immediate post operative outcome among the groups. 2.To compare patient’s comfort and surgeon’s satisfaction during surgery among the groups.
3. To compare side effects and hemodynamic variations from baseline among both the drugs.
|
Upto 4 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
Final Enrollment numbers achieved (Total)= "146"
Final Enrollment numbers achieved (India)="146" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/03/2024 |
| Date of Study Completion (India) |
01/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [swetha.yadavalli99@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
All the patients will be undergo Pre-anaesthetic check-up including detailed history and clinical examination and investigations. The patients wil be counselled in detail about sedation, LA and operative procedure.The visual analogue scale (VAS)(0-10, where 0 indicated no pain while 10 indicated maximum pain) will be explained to the patients. Pre-operatively patients will be advised to remain nilby mouth for at least 8 hours for heavy fatty meal,6 hours for solid food, 2 hours for clear liquids. Patient will be shifted to operation theatre after confirming about fasting and consent. All baseline vital parameters; HR, SBP, DBP,MAP and SpO2 will be recorded by multi•para monitor. All the demographic variables will be recorded. Ringer lactate solution will be started after Intravenous(IV) access is secured. All eligible patients will be allocated in two groups randomly by block randomization. The anaesthesiologistconducting the case, patients and anaesthesiologist in the post anaesthesia care unit (PACU) were all blinded to group assignment. Blinded observer records the data and the anaesthesiologist who did not participate in patient management or data collection will be preparing the drug. Group D :This group will receive nj. Dexmedetomidine 1mcg/kg in 10ml NS (normal saline ) over 10 minutes IV followed by it’s infusion at a rate of 0.2 mcg/kg/hr through infusion pump. Group P : This group will receive a dose of inj.Pentazocine 0.6mg/kg and inj. Promethazine 0.5mg/kg IV in 10 ml NS over 10minutes followed by infusion of 0.2 mcg/kg/hr of NS through infusion pump. The target end point of sedation will be aimed at maintaining a RSS 3 throughout the surgery.
LA anaesthesia will be administered by surgeon using 2% Lignocaine with Adrenaline (1:1,00,000) to block the greater auricular, lesser occipital, auriculotemporal nerves and four quadrants of the external auditory canal . After RSS of 3 was achieved 2% lignocaine and adrenaline (1:1,00,000) will be used for the infiltration of operative field. Surgery will commenced after confirmation of adequate analgesia. Patient’s response to LA infiltration will be evaluated for pain and body movement. Pain will be recorded on a scale of 10 VAS. Vital parameters will be recorded intra operatively every 5 minutes for first 30 minutes of surgery and 15 minutes intervals till the end of surgery. At every 30 minutes sedation level will be assessed by RSS, if RSS was <3 IV midazolam 0.01 mg/kg will be administered in either group. Similarly, inadequate analgesia will be treated by asking surgeon to infiltrate additional doses of 2% Maintenance infusion will be discontinued 15-20 minutes before the end of surgery at the time of skin closure. All adverse events like bradycardia (HR < 45 beats/min ), hypotension( MAP <50 mm hg sustained for > 10 min),respiratory depression ( respiratory rate < 10 breaths/min ), oxygen desaturation( SPO2 <90 %), nausea or vomiting will be recorded. Bradycardia will be managed by IV inj. Atropine and IV fluids or inj. Mephenteramine used for management of hypotension. Number of times patient had movement during surgical procedure will be recorded. Patient will be shifted to post anaesthetic care unit and monitored for haemodynamic parameters, analgesia , and adverse events if any within 4 hours after completion of surgery. Every 30 minutes RSS will be assessed and first rescue analgesic will be given at VAS > 4 and will be documented. Patients will be observed for 4 hours post operatively, during which patient’s satisfaction by IOWAscale, pain and sedation related data, Modified Aldrete score and any other remarks will be recorded.All data will be recorded in a structured case record form. |