| CTRI Number |
CTRI/2021/03/032061 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of Dexmedetomidine versus Midazolam and Fentanyl combination on post-operative psychomotor functions and recovery |
|
Scientific Title of Study
|
To compare the effect of dexmedetomidine versus midazolam and fentanyl combination on post-operative psychomotor functions and recovery in patients after middle ear surgeries done under local anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhinav Goyal |
| Designation |
Postgraduate Student |
| Affiliation |
Bhagat Phool Singh Government Medical College |
| Address |
Department of Pharmacology
BPS GMC for Women,
Khanpur Kalan,
Sonipat
Sonipat
HARYANA
131305
India |
| Phone |
8398016665 |
| Fax |
|
| Email |
abhinavgoyal1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Bhutani |
| Designation |
Associate Professor |
| Affiliation |
Bhagat Phool Singh Government Medical College |
| Address |
Department of Pharmacology
BPS GMC for Women,
Khanpur Kalan,
Sonipat
Sonipat
HARYANA
131305
India |
| Phone |
9992108132 |
| Fax |
|
| Email |
garimaahuja2010@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinav Goyal |
| Designation |
Postgraduate Student |
| Affiliation |
Bhagat Phool Singh Government Medical College |
| Address |
Department of Pharmacology
BPS GMC for Women,
Khanpur Kalan,
Sonipat
Sonipat
HARYANA
131305
India |
| Phone |
8398016665 |
| Fax |
|
| Email |
abhinavgoyal1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| BPS Govt. Medical College for Women, Khanpur Kalan
Sonepat (Haryana) |
|
|
Primary Sponsor
|
| Name |
BPS Govt Medical College for Women |
| Address |
BPS Govt. Medical College for Women, Khanpur Kalan
Sonepat (Haryana) |
| 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 |
| Dr Abhinav Goyal |
BPS Govt. Medical College for Women |
Department of Anesthesia and Post Anesthesia care unit
BPS Govt. Medical College for Women, Khanpur Kalan
Sonipat
HARYANA |
8398016665
abhinavgoyal1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECBPSGMC, BPS GOVERNMENT MEDICAL COLLEGE FOR WOMEN KHANPUR KALAN GOHANA SONEPAT HARYANA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
dexmedetomidine, a newly developed drug being used clinically for sedation in intensive care units has shown exciting prospects. It is an α‑2 agonist acting on adrenoceptors in many tissues including the nervous, cardiovascular, and respiratory systems. This α-2 adrenergic receptor agonist has sedative, analgesic and sympatholytic effects and is now widely used as an adjuvant in general anesthesia, spinal canal anesthesia, nerve block anesthesia, topical anesthesia and postoperative analgesia. Dexmedetomidine has a half-life of 2 hours. It acts on the central nervous system at the locus coeruleus, where it induces electroencephalographic activity similar to natural sleep. It also reduces catecholamine secretion, thereby reducing stress and leading to a modest decrease in heart rate and blood pressure.
Patients will receive injection dexmedetomidine 1μg/kg IV over 10 minutes followed by continuous infusion starting at 0.3 μg/kg/hr. This will be incremented by 0.1 μg/kg/hr up to 0.7 μg/kg/hr till adequate sedation score is achieved |
| Comparator Agent |
Midazolam and fentanyl combination |
Midazolam is a type of benzodiazepine. It has a rapid onset, a short duration of action and various pharmacologic properties such as anxiolytic, hypnotic and anterograde amnesic effects. Midazolam increases pain perception. In low‑dose midazolam has little influence on circulatory dynamics. Midazolam has a half‑life of 2.5 hours, and after repeated administration, there may be delayed recovery and hangover effects, such as excessive sleepiness and psychomotor impairment. Moreover, it also depresses the ventilator response to carbon dioxide and results in respiratory depression.
Fentanyl is a member of the phenylpiperidine class of opiate agents. It is a μ-selective opioid agonist used in severe cases of pain in patients with renal failure owing to its primarily hepatic elimination. Its high lipid solubility allows rapid entry across the blood–brain barrier, resulting in a rapid onset of action which is less than 60 seconds. It has a half-life of 90 minutes and duration of action of nearly 30–60 minutes. Its peak effect is within 2–5 minutes of drug administration. Fentanyl usually exerts its analgesic effect at 1–1.5 mcg/kg. For moderate sedation, it is used with midazolam and its dose is titrated.
Patients will receive injection midazolam 0.03 mg/kg IV and injection fentanyl 1 μg/kg IV bolus over 10 minutes followed by continuous infusion of midazolam 0.03 – 0.07 mg/kg/hr and fentanyl 0.5 – 1.5 μg/kg/hr till adequate sedation score is achieved |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to give written informed consent to participate in the study.
2. Patients aged between 18 and 60 years undergoing middle ear surgery done under local anesthesia.
3. Patients fit for the procedure according to Pre Anesthetic Checkup.
4. Patients who are literate at least up to 5th standard or more.
5. Patient having physical status of 1 and 2 according to American Society of Anesthesiologists |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to give written informed consent.
2. Patients having a history of any neurological or psychological disease.
3. Patients who have a history of hypersensitivity to any of the study drugs or any contraindication to any drug involved in this study.
4. Patients who are taking any medicine that affects psychomotor functions. |
|
|
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 effect of dexmedetomidine versus midazolam & fentanyl combination on post-operative psychomotor functions after middle ear surgeries done under local anesthesia |
Baseline psychomotor assessment and delirium assessment will be done 30 minutes prior to the shifting of patient to operation theatre and after completion of surgery both will be assessed at 1hour, 2 hour, 4 hour and 8 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on anesthesia recovery in post-operative period |
Anesthesia recovery will be assessed at every 30 minutes starting from the time of shifting of patient to post anesthesia care unit till the time patient is discharged from Post anesthesia care unit. |
| To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on post-operative pain and sedation |
Pain of the patient will be assessed every 30 minutes starting from the time of shifting of patient to post anesthesia care unit till the time patient is discharged from PACU
Intra operative Sedation level will be assessed every 10 minutes.Post operative sedation will be at 1 hour, 2 hour, 4 hour and 8 hours after completion of surgery
|
| To compare the effect of dexmedetomidine versus midazolam & fentanyl combination on hemodynamic parameters in post-operative period |
Hemodynamic parameters will be checked 30 minutes prior to surgery and at every 15 minutes for first 30 minutes during the surgery and then at every 30 minutes till the end of surgery. In post-operative period, parameters will be checked at every 30 minutes till the patient is discharged from PACU |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2021 |
| Date of Study Completion (India) |
05/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to compare the effect of dexmedetomidine versus midazolam and fentanyl combination on post-operative psychomotor functions and recovery in patients after middle ear surgeries done under local anesthesia. Thus this study will help us to choose a better sedative drug for short duration surgeries, so as to provide better sedation and analgesia to patients along with the advantage of producing lesser impairment of their psychomotor functions.
|