| CTRI Number |
CTRI/2023/07/055823 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of nebulised Dexmedetomidine Spinal Anaesthesia- a one year hospital based clinical trial |
|
Scientific Title of Study
|
Study of effect of nebulised Dexmedetomidine on onset and duration of Spinal Anaesthesia- a one year hospital based randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishabh G Mankale |
| Designation |
MBBS, Post Graduate of Anaesthesia |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
KLE Prabhakar Kore Hospital and KLE Prabhakar Kores Charitable Hospital, KLE Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9740584234 |
| Fax |
|
| Email |
rishabhmankale@rocketmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana A Gogate |
| Designation |
Professor, Department of Anaesthesia |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
KLE Prabhakar Kore Hospital and KLE Prabhakar Kores Charitable Hospital, KLE Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
vandanagogate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishabh G Mankale |
| Designation |
MBBS, Post Graduate of Anaesthesia |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
KLE Prabhakar Kore Hospital and KLE Prabhakar Kores Charitable Hospital, KLE Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9740584234 |
| Fax |
|
| Email |
rishabhmankale@rocketmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Prabhakar Kore Hospital and Research Centre, KLE Campus, Nehru Nagar Belagavi |
|
|
Primary Sponsor
|
| Name |
Other |
| Address |
Other |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vandana Gogate |
KLE Prabhakar Kore Charitable Hospital, Nehru Nagar, Belagavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rishabh G M |
KLE Dr Prabhakar Kore Hospital and Dr Prabhakar Kore Charitable Hospital |
Department of Anaesthesiology, Dr PKH and Research Centre, KLE Campus, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA |
9740584234
rishabhmankale@rocketmail.com |
| Dr Vandana A Gogate |
KLE Dr Prabhakar Kore Hospital and Dr Prabhakar Kore Charitable Hospital |
KLE Campus, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA |
9844083030
vandanagogate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Comittee |
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 |
Nebulized Dexmedetomidine at the dose of 1mcg/kg Body Weight is taken and diluted up to 5 ml with Normal Saline.
Nebulisation is continued until the nebuliser chamber is empty or only mist is present |
| Comparator Agent |
NORMAL SALINE |
5 ml of NORMAL SALINE is taken into the nebuliser chamber before starting nebulisation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I to II
Patients undergoing elective infra-umbilical surgery under Spinal Anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with ASA Grade III and above
Patients contraindication to Spinal Anaesthesia
Patients with known allergy to Dexmedetomidine
Patients on pre-operative drugs that could be potential confounders such as Clonidine, Gabapentin, Pregabalin, Steroids etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of nebulised Dexmedetomidine on onset and duration of sensor and motor block in Spinal Anaesthesia |
Monitored every 5 min upto 30 minutes then every 10 minutes upto the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time for first rescue analgesia
Total analgesic requirement in the first 24 hours post-operatively
To study the side effects of the drug, if any |
Monitored every 5 min upto 30 minutes then every 10 minutes upto the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/08/2023 |
| Date of Study Completion (India) |
27/12/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining approval from the Ethical Committee, and applying inclusion and exclusion criteria, subjects undergoing infra-umbilical surgery in supine position under Spinal anaesthesia will be included in the study.
Data collection procedure: In the Pre-operative area After obtaining approval and consent for the study, patient’s details are elicited, and NBM status is confirmed. Pulse Oximeter, NIBP, ECG leads are attached and baseline reading is taken in the Preoperative room. Patient will be shifted into the OT. Baseline pulse,NIBP and SpO2 will be recorded. Patient will then receive Spinal anaesthesia in L3-L4 space with 3.2ml of 0.5% Hyperbaric Bupivacaine. Intraoperative Pulse, SpO2, NIBP will be monitored every 5 minutes upto 30 minutes and then every 10 minutes till the end of surgery. After the action of spinal anaesthesia, patient will receive nebulisaion. Group I will receive dexmedetomidine nebulisation with maximum of 1mcg/kg diluted with Normal Saline upto 5 ml. Patients in Group II will receive nebulisation with 5 ml of saline. Onset of Sensory and Motor blockade is noted. Onset and duration of Sensory blockade is noted with cold swab. Motor blockade is assessed with Bromage Scale with the following score:- 0- No paralysis 1- Unable to flex hip, but able to flex knees and ankle 2- Unable to flex hips and knees, but able to flex ankles 3- Unable to flex ankles, only able to move toes. 4- Total paralysis Time for regression of sensory block by 2 segments is noted as duration of Sensory Blockade. Duration of time taken for Bromage score 0 to return is noted as duration of Motor blockade. Intraoperative fall in HR over 15% of baseline will be treated with Inj. Atropine 0.6mg IV while fall in BP>20% will be treated with 3 mg of Mephentermine IV if required. Intraoperatively sedation will be assessed using Ramsay sedation score every half hourly till the duration of surgery or for 3 hours whichever is longer. Post Operatively- Pain will be evaluated using the VAS Scale. When VAS>3, patient will receive Inj. Paracetamol 15mg/Kg BW. The time at which patient asks for analgesic is noted and the total analgesic consumption in the First 24 hours is noted. |