| CTRI Number |
CTRI/2022/01/039437 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
13/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different drugs as Adjuvants in spinal anesthesia for Abdominal Hysterectomy surgeries. |
|
Scientific Title of Study
|
Comparison of the Postoperative Analgesia between Fentanyl and Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine for Abdominal Hysterectomy Patients in a Tertiary Care Centre in Kerala |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijitha Baby |
| Designation |
P G RESIDENT |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla |
| Address |
Department of Anaesthesiology
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
9446801383 |
| Fax |
|
| Email |
vijithababy10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mathews K Thomas |
| Designation |
Associate Professor |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla |
| Address |
Department of Anaesthesiology
Pushpagiri Institute of Medical sciences and Research Centre
Tiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
7356879388 |
| Fax |
|
| Email |
mathewskthomas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijitha Baby |
| Designation |
P G RESIDENT |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla |
| Address |
Department of Anaesthesiology
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
9446801383 |
| Fax |
|
| Email |
vijithababy10@gmail.com |
|
|
Source of Monetary or Material Support
|
| PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, TIRUVALLA |
|
|
Primary Sponsor
|
| Name |
PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
TIRUVALLA
KERALA
689101 |
| Type of Sponsor |
Private 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 |
| VIJITHA BABY |
PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
TIRUVALLA
Pathanamthitta
KERALA |
9446801383
vijithababy10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,TIRUVALLA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRATHECAL BUPIVACAINE WITH DEXMEDETOMIDINE |
3ml 0.5% Bupivacaine with 10mcg DEXMEDETOMIDINE given in SAB.
Duration of postoperative analgesia noted in total abdominal hysterectomy patients |
| Comparator Agent |
INTRATHECAL BUPIVACAINE WITH FENTANYL |
3ml 0.5% Bupivacaine with 25mcg FENTANYL given in SAB.
Duration of postoperative analgesia noted in total abdominal hysterectomy patients |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Female |
| Details |
PATIENTS OF ASA STATUS 1 & 2 |
|
| ExclusionCriteria |
| Details |
1.PATIENT REFUSAL
2.PATIENT ON ALPHA BLOCKERS, BETA BLOCKERS DRUGS
3.PATIENT SENSITIVE OR ALLERGIC TO STUDY MEDICATIONS
4.PATIENTS OF ASA STATUS 3 & 4 |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
TIME OF RESCUE ANALGESIA
|
VAS SCORE ASSESSED AT 1hr 2hr 3hr 4hr 6hr 12hr 24hr
RESCUE ANALGESIA GIVEN WHEN VAS SCORE MORE THAN 4 OR ON PATIENT REQUEST
TIME IN MINUTES NOTED
DURATION OF ANALGESIA NOTED
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TIME OF ONSET OF SENSORY BLOCK |
BY PIN PRICK METHOD
GRADE 0 NO SENSATION FELT |
| TIME OF ONSET OF MOTOR BLOCK |
BY MODIFIED BROMAGE SCALE
SCORE 3 |
| DURATION OF SENSORY BLOCK |
GRADE 2 ON PIN PRICK |
| DURATION OF MOTOR BLOCK |
MODIFIED BROMAGE SCALE SCORE 0 |
| HEART RATE |
5,10,15,20,25 and 30min after injection and subsequently every 15 min. |
| SYSTOLIC AND DIASTOLIC BLOOD PRESSURE |
5,10,15,20,25 and 30min after injection and subsequently every 15 min. |
| SPO2 |
5,10,15,20,25 and 30min after injection and subsequently every 15 min. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/01/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Patients planned for elective procedures will be approached prior to the study and patient information sheet will be given Pre-anaesthetic checkup will be done on the day before surgery. An informed consent will be taken, and patient will be kept nil per oral for 6 hours prior to surgery. Premedication with T. Pantoprazole 40mg, T. Metoclopramide 10mg and T. Alprazolam 0.25mg will be given on the previous night and in the morning. The visual analogue system will be explained to all patients. IV access will be secured before the procedure. Preloaded with ringer lactate 500ml. Vital parameters will be monitored before and during the surgery using pulse oximetry, BP , continuous ECG, etc. Baseline hemodynamic parameters will be measured (SBP, MAP, HR, DBP) Inj. Ondansetron(4mg) and Inj. Midazolam(1 mg) will be administered IV 15 minutes prior to surgery. Spinal anaesthesia to be administered with the patients in left lateral position at L3L4 space with 23-25 gauge spinal needle. The drug to be loaded and handed over by one person not related to the study.
Group 1-patients to receive 0.5% bupivacaine 3ml with 0.5ml (25µg) fentanyl Group 2- patients to receive 0.5% bupivacaine 3ml with 0.5ml (10µg) dexmedetomidine intraoperatively monitoring of blood pressure, pulse rate and saturation done at 5,10,15,20,25 and 30min after injection and subsequently every 15 min. Onset of sensory blockade and onset of complete motor blockade to be recorded Sensory block assessed by pinprick method motor block assessed by Modified Bromage scale Duration of sensory and motor blockade to be noted Postoperatively pain score(VAS) assessed at 1hr for first 4h and at 6,12and24h; rescue analgesics will be given when VAS score is more than 4 or on patient request for pain relief; duration of analgesia to be noted. Any fall in heart rate below 50/min to be treated with atropine 0.6mg Fall in systolic blood pressure below 20% of the baseline to be managed with inj. Ephedrine 6 mg in increments. Any signs of respiratory depression noted to be dealt with oxygen supplementation and assisted ventilation. Data collected will be entered on study proforma
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