| CTRI Number |
CTRI/2025/04/084823 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study To Compare Effects Of Isobaric Levobupivacaine with isobaric Ropivacaine In Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
To Compare Effects of Inj Levobupivacaine (isobaric) and Inj Dexmedetomidine with Inj Ropivacaine (Isobaric) and Inj Dexmedetomidine in Segmental Spinal in Patients Posted For Laparoscopic Cholecystectomy |
| Trial Acronym |
SEGLAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Jalaun |
| Address |
Department of Anesthesia and Critical Care
First Floor Room number 2
Government Medical College , Jalaun ( Orai)
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
anilkgmu10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Jalaun |
| Address |
Department of Anesthesia and Critical Care
First Floor Room number 2
Government Medical College , Jalaun ( Orai)
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
anilkgmu10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Jalaun |
| Address |
Department of Anesthesia and Critical Care
First Floor Room number 2
Government Medical College , Jalaun ( Orai)
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
anilkgmu10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Jalaun ( Orai) |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Jalaun( Orai) |
| Address |
Department of Anesthesia and Critical Care |
| 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 Anil Kumar |
Government Medical college Jalaun |
Department of Anesthesia and Critical Care, Government Medical College Jalaun
Jalaun
UTTAR PRADESH |
9454224498
anilkgmu10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government Medical college Jalaun Institute Ethical Committee ( Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection levobupivacaine |
1.5ml (7.5mg), Intrathecal, once at the time of induction in 1 min |
| Comparator Agent |
injection Ropivacaine |
1.5ml ( 11.25mg ), intrathecal, once at the time of induction in 1 min |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with chronic cholelithiasis with cholecystitis
2. Age group between 40 to 60 years |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled Diabetes and Hypertension.
2. Chronic renal diseases
3. Chronic anemia
4. I.H.D. or any other cardiac condition.
5. Peripheral vascular disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hemodynamic stability |
1st hours postinduction period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| shoulder tip pain |
1st hour at induction |
|
|
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 4 |
|
Date of First Enrollment (India)
|
25/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 27-07-2025 and end date provided 27-07-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Laparoscopic
surgery is normally performed under general anesthesia, but regional techniques
such as thoracic epidural and lumbar spinal have been emerging and found
beneficial. We performed a clinical study of segmental thoracic spinal
anesthesia in a patients using injection levobupivacaine ( isobaric) and injection dexmedetomidine injected at T10-11 intervertibral space; effects is ben monitored for the changes in the hemodynamic stability and incidence of the shoulder tip pain |