| CTRI Number |
CTRI/2019/01/017322 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of drug Bupivacaine alone with Bupivacaine and Midazolam given in spinal analgesia for operations in lower half of body. |
|
Scientific Title of Study
|
Comparison of intrathecal Bupivacaine and Bupivacaine plus Midazolam in spinal analgesia. |
| Trial Acronym |
Bupivacaine, Midazolam, Spinal analgesia |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanhaiya Lal Kishnani |
| Designation |
Associate Professor |
| Affiliation |
Peoples college of Medical Sciences & R C Bhanpur Bhopal |
| Address |
Department of Anaesthesia
Peoples College of Medical Sciences & Research Center Bhanpur Bhopal
Department of Anaesthesia Peoples College of Medical Sciences Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554004010 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanhaiya Lal Kishnani |
| Designation |
Associate Professor |
| Affiliation |
Peoples college of Medical Sciences & R C Bhanpur Bhopal |
| Address |
Department of Anaesthesia
Peoples College of Medical Sciences & Research Center Bhanpur Bhopal
Department of Anaesthesia Peoples College of Medical Sciences Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554004010 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanhaiya Lal Kishnani |
| Designation |
Associate Professor |
| Affiliation |
Peoples college of Medical Sciences & R C Bhanpur Bhopal |
| Address |
Department of Anaesthesia
Peoples College of Medical Sciences & Research Center Bhanpur Bhopal
Department of Anaesthesia Peoples College of Medical Sciences Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554004010 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples college of Medical Sciences & R C Bhopal |
|
|
Primary Sponsor
|
| Name |
Peoples College of Medical Sciences R C |
| Address |
Peoples college of Medical Sciences & Research Center Bhanpur Bhopal |
| 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 |
| Dr K L Kishnani |
Operation Theatre, Peoples Hospital, Peoles College of Medical Sciences & Research Centre Bhopal |
Operation Theatre, Peoples Hospital, Peoples College of Medical Sciences & Research Centre Bhanpur Bhopal M.P.
Bhopal
MADHYA PRADESH |
4004010
drkishnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Peoples Medical College & R C Bhanpur Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R50-R69||General symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine heavy 0.5% and Midazolam. |
50 patients will receive 3.0 ml of Bupivacaine heavy 0.5% and 0.4 ml of (5.0 mg/ml) preservative free Midazolam intrathecally. |
| Comparator Agent |
Bupivacaine heavy 0.5% and normal saline, |
50 patients will receive 3.0 ml of Bupivacaine heavy 0.5% and 0.4 ml of normal saline intrathecally, |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Total 100 patients of ASA Grade I and II between the age group of 25 to 50 years of age undergoing surgery below umbilicus under spinal analgesia will be taken. |
|
| ExclusionCriteria |
| Details |
Patients with H/O long-term uncontrolled hypertension, uncontrolled DM cases, known neurologic or psychological disorders, spinal column surgery, with low back pain, chronic alcoholism, opium addiction or on any drug that modifies pain will not be included in this study. Patient with coagulation abnormality, patient with infection at the site of injection will also be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
After lumber puncture drugs will be injected.Patients will be positioned supine at Highest dermatome sensory block level will be assessed.Time of regression of sensory & motor block will be noted.Time for recovery of motor blockade to L 2 (hip flexion) will be noted.Time of first rescue analgesia will be noted.
The patients will also be observed for any side effect;and treated if appeared.
|
After lumber puncture drugs will be injected over period of 15 seconds. Patients will be positioned supine at least 20 minutes. Highest dermatome sensory block level will be assessed.Vitals of patients will be monitored during surgery. Time for four segment regression of sensory blockade will be noted.Time for recovery of motor blockade to L 2 (hip flexion) will be noted.Time of first rescue analgesia will be noted.Patients will be observed for side effects and treated.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The block produced by drug combinations injected will be studied |
The duration and quality of block and side effects if any will be studied intaopertively & post operatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
11/02/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be sent for publication after study completion. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total 100 patients of ASA group I and II between 25 and 50 years of age undergoing surgery below umblicus under spinal analgesia will be studied. The patients will divided in two groups of 50 patients each. patients of group B will receive 3.0 ml of ) 0.5% Bupivacaine heavy and 0.4 ml of Normal Saline, while patients of group BM will receive 0.5% Bupivacaine heavy and 0.4 ml (5.0 mg) of preservative free Midazolam. The drugs will be prepared by separate anaesthsiologist not involved in the study and will be given by separate anaesthesiologist. Patients of both the groups will be pre-loaded with 15 ml of Ringer Lactate solution before spinal analgesia. On arrival in operation theatre patients will be monitored with ECG, Non invasive blood pressure, Heart rate and pulse oximetery. The parameters will be recorded as base line. With full aseptic precautions lumber puncture will be performed in sitting position in L 3- 4 space by mid line approach in all patients. Lumber puncture will be performed with 25 gauge Quinke spinal needle. After successful lumber puncture the drug will be injected in 15 seconds and patient will be placed in supine position with slight elevation of head (15 to 20 degrees) for at least 20 min before positioning for surgery. The highest dermatome level of sensory block will be assessed by short bevel injection needle after bliding the patient’s eyes in mid axillary line bilaterally . The process of assessing the block will be explained to patients before procedure. Intraoperative ECG, heart rate, blood pressure and Spo2 will be monitored. Hypotension and bradycardia if noted will be treated with I/V Ephedrine 5 to 10 mg and Crystalloid solution. Bradycardia will be treated with I/V Atropine 0.6 mg . Time for four segment sensory block regression will be noted and recorded. Time of recovery of motor block to L 2 level (Hip flexion) will be recorded. Post operative analgesia will be evaluated by Standard Visual Analogue Scale (0-10). The patients will be requested to inform immediately the feel of pain and time will be noted. The time of first rescue analgesia will be noted. The patients will be observed for any side effects and will be noted and treated if any appeared. |