| CTRI Number |
CTRI/2013/04/003600 [Registered on: 30/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/04/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of adding midazolam to bupivacaine during spinal anaesthesia |
|
Scientific Title of Study
|
A study to compare the analgesic efficacy of intrathecal bupivacaine alone with intrathecal bupivacaine midazolam combination in patients undergoing elective infra-umbilical surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anirban Chattopadhyay |
| Designation |
Ex resident, Dept of anaesthesiology, IPGME&R, Kolkata |
| Affiliation |
IPGME&R and SSKM hospital, Kolkata |
| Address |
Junior Doctors Hostel,
242 AJC Bose Rd, Kolkata- 20
Kolkata
WEST BENGAL
700020
India |
| Phone |
09867198844 |
| Fax |
|
| Email |
smaitra.ipgmer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kakali Ghosh |
| Designation |
Assistant Professor, Department of Anaesthesiology, IPGME&R, Kolkata. |
| Affiliation |
IPGME&R and SSKM hospital, Kolkata |
| Address |
83, Dumdum Park, Kolkata - 55
Kolkata
WEST BENGAL
700055
India |
| Phone |
09339748242 |
| Fax |
|
| Email |
gkakali354@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anirban Chattopadhyay |
| Designation |
Ex resident, Dept of anaesthesiology, IPGME&R, Kolkata |
| Affiliation |
IPGME&R and SSKM hospital, Kolkata |
| Address |
Junior Doctors Hostel,
242 AJC Bose Rd, Kolkata- 20
WEST BENGAL
700020
India |
| Phone |
09867198844 |
| Fax |
|
| Email |
smaitra.ipgmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER, SSKM Hospital, Kolkata |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Medical Education and Reseach Kolkata |
| Address |
244, AJC Bose Road, Kolkata- 20 |
| 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 Anirban Chattopadhyay |
IPGME&R and SSKM Hospital, Kolkata |
Department of anaesthesiology, Main OT, 3rd floor, Main block, IPGME&R and SSKM Hospital, 244 AJC Bose road, Kolkata 20
Kolkata
WEST BENGAL |
09867198844
smaitra.ipgmer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, IPGME&R, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I and II patients posted for elective infra umbilical surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intrathecal midazolam along with bupivacaine were compared with bupivacaine alone. |
After obtaining institutional ethics committee clearance, and written informed consent from the patients, 90 adult patients of ASA physical status I and II and aged 18 – 60 years undergoing elective infra-umbilical (gynaecologic/urologic) under spinal subarachnoid block anesthesia were included into the study. Patients of group BM received 2.5ml hyperbaric bupivacaine (0.5%) plus 0.4 ml (2mg) preservative free midazolam, Patients of group B received 2.5 ml hyperbaric bupivacaine (0.5%) plus 0.4 ml normal saline (0.9%). The total volume of subarachnoid injectate in either group was 2.9 ml. |
| Intervention |
Spinal subarachnoid block |
Under strict aseptic precautions a 25G Quincke spinal needle was introduced into L3-L4 or L4-L5 inter vertebral space in midline approach in lateral posture and after confirming free flow of CSF, pre determined 2.9 ml of drug solution was injected. The rate of injection was kept 0.2 ml/second. At the end of the injection, a small sterile dressing was applied and patients were placed supine with a pillow under the head and neck soon after administration of intrathecal drugs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
adult patients of ASA physical status I and II and aged 18 – 60 years undergoing elective infra-umbilical (gynaecologic/urologic) under spinal subarachnoid block anesthesia were included into the study |
|
| ExclusionCriteria |
| Details |
Patients refusing to participate,
Patients with known allergic to local anaesthetic and midazolam,
Patients suffering from chronic pain, and
pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
time from administration of block to demand of first rescue analgesia in post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of motor block
Hemodynamic changes |
Intraoperative & postoperative period |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2009 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Background:
Spinal anesthetic technique is one of the common procedures used for various
infra umbilical surgeries. Duration of post operative analgesia is one of the
important concerns while performing this
procedure. Several adjuvants have been tried along with local anesthetic for
prolonging the duration of analgesia. In this study we have observed the effect
of midazolam as an adjuvant in patients undergoing infra umbilical surgery.
Settings
and Design: A prospective, randomized, double blinded, parallel group, placebo
controlled, open label study tertiary care hospital.
Methods:
90 adult patients aged 18 – 60 years, of American Society of Anaesthesiologists
(ASA) status I and II, scheduled for elective infraumbilical surgery, were randomly
allocated in two groups. Each patient in
group “B†received bupivacaine 12.5mg along with 0.4 ml of normal saline
in the subarachnoid block, and patients of group “BM†received 12.5 mg
bupivacaine along with preservative free midazolam 0.4ml (2mg). Duration of
analgesia was calculated from time of administration of the block to
requirement of rescue analgesic as demanded by the patient in the post
operative period.
Statistical
analysis: SPSS v17.0 was used for analysis of data. A p-value < 0.05 was
considered statistically significant.
Results
& conclusion: Use of midazolam as adjuvant with the local anesthetic
significantly increases the duration of analgesia and motor block but a less
PONV.
|