CTRI Number |
CTRI/2023/11/059631 [Registered on: 07/11/2023] Trial Registered Prospectively |
Last Modified On: |
06/11/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Case Control Study |
Study Design |
Other |
Public Title of Study
|
Heavy ropivacaine with and without dexmedetomidine as an adjuvant in spinal anaesthesia for caesarean section |
Scientific Title of Study
|
Effect of hyperbaric ropivacaine with and without dexmedetomidine as an adjuvant in spinal anaesthesia for caesarean section:A prospective observational study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr.Mohammadfaizan Kanuga |
Designation |
MD Anaesthesiology Resident |
Affiliation |
Government medical college surat gujarat india |
Address |
Government Medical College New Civil Hospital Surat
Gujarat
395001
India
Surat GUJARAT 395001 India |
Phone |
9913926780 |
Fax |
|
Email |
kfaizangmers@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr.Bansari Kantharia |
Designation |
Additional Professor |
Affiliation |
Government medical college new civil hospital surat gujarat |
Address |
Government medical college new civil hospital surat gujarat
395001
india
Surat GUJARAT 395001 India |
Phone |
9825690177 |
Fax |
|
Email |
bansarikantharia@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr.Bansari Kantharia |
Designation |
Additional Professor |
Affiliation |
Government medical college new civil hospital surat gujarat |
Address |
Government medical college new civil hospital surat gujarat
395001
india
Surat GUJARAT 395001 India |
Phone |
9825690177 |
Fax |
|
Email |
bansarikantharia@gmail.com |
|
Source of Monetary or Material Support
|
Government medical college surat,gujarat |
|
Primary Sponsor
|
Name |
Mohammadfaizan kanuga |
Address |
Government medical college new civil hospital surat,gujarat 395001 |
Type of Sponsor |
Other [Self] |
|
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 Mohammadfaizan Kanuga |
Government medical college and new civil hospital |
Department of anaesthesiology Surat GUJARAT |
9913926780
kfaizangmers@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Human research ethics committe, government medical college surat |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
1)Patients posted for elective or emergency caesarean section receiving spinal anaesthesia
2) Patients in the age group of 18-40 years
3)Patients having height of 145-165cm
4) Patients belonging to ASA grade I, II or III
5) Patients giving written informed consent
|
|
ExclusionCriteria |
Details |
1)Contraindication to spinal anaesthesia
(Patient Refusal, Coagulopathy, localized infection and neurological diseases, allergy to study drugs)
2)Patient having major cardio-respiratory disorders or major hepato-renal disorders
3)Multifetal pregnancies
4)Suspected fetal abnormalities
5)Fetal compromised
6)Severe PIH
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1)Onset and duration of sensory &motor blockade
2)Duration of post operative analgesia and 24 hours analgesic requirement
|
24 hours
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1)Hemodynamic parameters
2)Adverse effects and side effects
|
24 hours |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
Date of First Enrollment (India)
|
20/11/2023 |
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="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Spinal anaesthesia is technique of choice for anaesthesia in patients undergoing caesarean section due to its rapid onset, surety of effect, decreased blood loss and good safety profile. With the advantage of avoiding maternal risk of general anaesthesia including failure of tracheal intubation, aspiration pneumonitis and lung infection. Ropivacaine, a long acting amino-amide local anaesthetic agent is similar to bupivacaine in chemical structure. Previous studies for isobaric ropivacaine for neuraxial blockage have been shown to be safe and effective [1]. Hyperbaric local anaesthetics produce predictable block characteristics and effective spinal anaesthesia. Dexmedetomidine, a highly selective alpha-2 adrenergic agonist provides sedative, analgesic, anti-sympathetic effects and has no significant effect on respiration. The results of previous study indicate that 5 microgram dexmedetomidine as an intrathecal adjuvant to 0.5% hyperbaric bupivacaine for caesarean section is useful as it hastens the onset of sensory and motor block and prolongs postoperative analgesia and motor blockage without producing significant hemodynamic changes, sedation and neonatal adverse effects [2]. As this technique and drugs being used routinely in our institute, we are just doing observation of what is happening. We are not doing any intervention in standard protocol of our institute. So this is a observational study. So, we aim to study the recently available hyperbaric ropivacaine and compare it with combination of hyperbaric ropivacaine and dexmedetomidine 5 microgram given intrathecally for lower segment caesarean section. |