| CTRI Number |
CTRI/2019/08/020760 [Registered on: 19/08/2019] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Fentanyl and Buprenorphine administered by different routes on spinal anesthesia |
|
Scientific Title of Study
|
Effect of Intrathecal versus Intravenous Fentanyl and Buprenorphine on spinal anesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navya C N |
| Designation |
Associate professor |
| Affiliation |
Sri Muthukumaran Medical College Hospital and Research Institute |
| Address |
Department of Anesthesiology
SMMCHRI
Chennai-600069
Chennai
TAMIL NADU
600069
India |
| Phone |
9791793965 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya C N |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Department of Anesthesiology
SMMCHRI
Chennai-600069
Chennai
TAMIL NADU
600069
India |
| Phone |
9791793965 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya C N |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Department of Anesthesiology
SMMCHRI
Chennai-600069
Chennai
TAMIL NADU
600069
India |
| Phone |
9791793965 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
|
Source of Monetary or Material Support
|
| self
Dr Navya CN
Associate professor
dept of Anesthesiology
SMMCHRI, Chennai-69 |
|
|
Primary Sponsor
|
| Name |
Sri muthukumaran medical colle hospital and research institute |
| Address |
chikkarayapuram, near mangadu, chennai 600069 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Navya C N |
Sri MuthuKumaran Medical College Hospital And Research Institute |
OT complex ground floor, Dept of anesthesiology
SMMCHRI,chikkarayapuram, near mangadu,
Chennai
TAMIL NADU |
9791793965
drcn.navya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri MuthuKumaran Medical College Hospital And Research Institute. instituional ethics committee ( human study) |
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 |
intarvenous and intrathecal route |
IV Fentanyl
IV buprenorphine
intathecal fentanyl
intrathecal buprenorphine
|
| Comparator Agent |
intravenous fentanyl
intravenous buprenorphine
intrathecal fentanyl
intrathecal buprenorphine |
Group A: (Control Group): receive intrathecal bupivacaine heavy 0.5% 2.5ml + 0.2 ml normal saline + 10 ml normal saline intravenously over 10 min after block.
Group B : receive intrathecal bupivacaine heavy 0.5% 2.5 ml + 0.2 ml normal saline + intravenous fentanyl at 2 mcg /kg diluted to 10 ml with NS over 10 min after block.
Group C: receive 2.5 ml intrathecal bupivacaine 0.5 % H + 20 mcg of intrathecal fentanyl + 10 ml of normal saline intravenous over 10 minutes after block.
Group D: receive 2.5 ml intrathecal bupivacaine 0.5 % H + 60 mcg of intrathecal Buprenorphine + 10 ml of normal saline intravenous over 10 minutes after block.
Group E : receive intrathecal bupivacaine heavy 0.5% 2.5 ml + 0.2 ml normal saline + intravenous buprenorphine at 2 mcg /kg diluted to 10 ml with normal saline over 10 min after block.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
60-70kg weight
170-180cms height
asa I, II
posted for elective perineal surgery |
|
| ExclusionCriteria |
| Details |
Patients with contraindications to narcotics and spinal anesthesia
Patient refusal
Haemorrhagic disorders
Local infection
Severe hypertension
Spinal deformity
Raised intracranial tension
Known hypersensitivity to local anaesthetic drug
Autonomic neuropathy
COPD
|
|
|
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 |
| post operative analgesia |
0-24 h post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
post operative complcations-Shivering
Nausea, Vomiting
Respiratory Depression
Pruritis
Sedation
|
intraopErative and postoperative period |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/08/2019 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study aims to compare the effects of
intrathecal and intravenous fentanyl and buprenorphine on duration of spinal
anaesthesia and to evaluate any advantages or disadvantages of intravenous over
intrathecal Fentanyl and buprenorphine in terms of analgesia, sedation,
post–operative shivering and hemodynamic stability. |