| CTRI Number |
CTRI/2019/04/018801 [Registered on: 26/04/2019] Trial Registered Prospectively |
| Last Modified On: |
25/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intravenous dexmedetomidine and paracetamol in bupivacaine spinal anesthesia |
|
Scientific Title of Study
|
A comparison of effects of intravenous dexmedetomidine and paracetamol in bupivacaine spinal anesthesia in lower abdominal and pelvic surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarabjeet Chhabra |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector-32 |
| Address |
D-block, Level 5, Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9805917372 |
| Fax |
|
| Email |
drsarabjeetchhabra@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Sector-32 |
| Address |
D-block, Level 5, Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarabjeet Chhabra |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector-32 |
| Address |
D-block, Level 5, Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9805917372 |
| Fax |
|
| Email |
drsarabjeetchhabra@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
D-block, Level 5, Government Medical College and Hospital, Sector 32, Chandigarh |
| 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 Sarabjeet Chhabra |
Government Medical College and Hospital |
Operation Theatre, Block C, Level 2
Chandigarh
CHANDIGARH |
9805917372
drsarabjeetchhabra@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh) |
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 |
Intravenous Dexmedetomidine |
Intravenous Dexmedetomidine given 15 minutes before giving spinal anaesthesia and thereby assessing the duration and quality of spinal block |
| Intervention |
Intravenous Paracetamol |
Intravenous Paracetamol given 15 minutes before giving spinal anaesthesia and thereby assessing the duration and quality of spinal block |
| Comparator Agent |
Normal Saline |
Normal Saline given 15 minutes before giving spinal anaesthesia and thereby assessing the duration and quality of spinal block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists (ASA) class I or II
2. Age: 18 to 70 years
3. Measuring 150-180 cm height, with body mass index (BMI) of 18-35 kg/m2
4. Patients undergoing elective lower abdominal and pelvic surgeries requiring spinal anaesthesia (maximum surgery duration-2hours)
|
|
| ExclusionCriteria |
| Details |
1. All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre-existing neurological deficits in lower extremities, unwillingness to give consent.
2. Sensory blockade inadequate for surgery.
3. Patients on alpha-2 adrenergic receptors antagonists, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
4. Patients having cardiac rhythm abnormalities.
5. History of alcoholism, drug abuse, and psychiatric disorders.
6. History of allergy to any of the study drugs.
7. Hepatic disease, renal disease, cardiopulmonary disease, hypertension,
diabetes, central or peripheral nervous system disorders.
8. Laparotomy, chronic abdominal pain undergoing treatment with opioid analgesic.
9. Pregnant patients.
10. Orthopaedic surgeries.
11. Surgeries extending more than 2 hours.
|
|
|
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 |
| 1. To compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries. |
Intra-operatively -
1. Time of T10 sensory block
2. Maximal sensory block achieved
3. Time of Bromage 3 motor block
Post-operatively -
1. Time to sensory regression (2 dermatomes)
2. Time to motor regression
(Bromage 1)
3. Time of first analgesic dose (VAS 3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the sedation score and adverse effects |
1. Sedation assessed by Modified Ramsay sedation scale.
2. Hypotension (decrease in mean arterial pressure below 20% of baseline or systolic pressure less than 90 mmHg)
3. Bradycardia (heart rate less than 50 beats/min)
Hemodynamic parameters recorded every 5 minutes during and after study drug administration till 30 minutes. Post 30 minutes recorded every 15 minutes and finally every 30 minutes in postoperative room until recovery from the block. |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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 4 |
|
Date of First Enrollment (India)
|
26/04/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, double-blind, randomized, placebo controlled trial to compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries. We aim to compare the effectiveness of the above drugs compared with placebo given 15 minutes before performing subarachnoid block on duration and quality of sensory block, motor block, and post operative analgesic requirement |