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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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