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CTRI Number  CTRI/2023/09/057280 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 22/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of effects of dexmedetomidine added to levobupivacaine and recemic bupivacaine for cesarean section under spinal anaesthesia. 
Scientific Title of Study   To determine the time of onset, time to attainment of maximum level and duration of sensory and motor blockade with Levobupivacaine heavy with Dexmedetomidine versus Racemic Bupivacaine Heavy with Dexmedetomidine in Spinal Anaesthesia for Cesaean Section 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Archana 
Designation  JUNIOR RESIDENT 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI 
Address  DEPARTMENT OF ANAESTHESIOLOGY, RIMS, BARIATU, RANCHI - 834009, JHARKHAND
KAMAL KUNJ AMBEDKAR PATH, SHIV GANJ, HARMU ROAD, RANCHI, JHARKHAND 834001
Ranchi
JHARKHAND
834001
India 
Phone  07033626390  
Fax    
Email  archanakamal1972@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Shrivastava 
Designation  Assistant Professor 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI 
Address  DEPARTMENT OF ANAESTHESIOLOGY, RIMS, BARIATU, RANCHI - 834009, JHARKHAND
THE EMPIRE 5TH FLOOR, REAR BLOCK, TAGORE ENCLAVE, MORABADI RANCHI, JHARKHAND 834008
Ranchi
JHARKHAND
834009
India 
Phone  9958912712  
Fax    
Email  shrivastava2911@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh Kumar 
Designation  Assisstant Professor 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI 
Address  DEPARTMENT OF ANAESTHESIOLOGY, RIMS, BARIATU, RANCHI - 834009, JHARKHAND
401 B , VIKRAMSHILA VATIKA, CHESIRE HOME ROAD, BARIATU, RANCHI, JHARKHAND-834009
Ranchi
JHARKHAND
834009
India 
Phone  7004993204  
Fax    
Email  mukeshgmch@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Insitute of Medical Sciences, Ranchi. Jharkhand. 834009.India. 
 
Primary Sponsor  
Name  Rajendra Insitute of Medical Sciences, Ranchi 
Address  Bariatu, Ranchi, Jharkhand, 834009 
Type of Sponsor  Government medical college 
 
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 Archana  Rajendra Insitute of Medical Sciences, Ranchi  Labour OT, 4th Floor, Old building, Rajendra Insitute of Medical Sciences, Ranchi, Jharkhand, 834009
Ranchi
JHARKHAND 
7033626390

archanakamal1972@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O99||Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine heavy with Dexmedetomidine  under full aseptic precaution, 0.5% levo bupivacaine heavy 2 ml with inj dexmedetomidine 5 micro gm will be given for spinal anaesthesia in L3 - L4 subarachnoid space. 
Comparator Agent  Racemic Bupivacaine Heavy with Dexmedetomidine   under full aseptic precaution, 0.5% recemic bupivacaine heavy 2 ml with inj dexmedetomidine 5 micro gm will be given for spinal anaesthesia in L3 - L4 subarachnoid space. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  The patient giving informed and written consent for study.

Primigravida posted for elective caesarean section with more than 37 weeks gestation.

Having singleton pregnancy.

 
 
ExclusionCriteria 
Details  The patient not giving consent for the study.

Pregnancy with height less than 145cm and more than 165cm.

patients having any contraindications for spinal anaesthesia.

Pregnant women with fetal anomaly, placenta previa, abruptio placenta, placenta percreta or increta. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the time of onset, time to attainment of maximum level & duration of sensory and motor blockade.  time of onset: zero minutes
Time to attainment of maximum level: time taken to reach anaesthesia at T6 dermatomal level.
Duration of sensory and motor blockade: from the time of induction (zero minutes) to regression of anaesthesia at T12 and movement of lower limb respectively. 
 
Secondary Outcome  
Outcome  TimePoints 
To record the haemodynamic parameters every minute in first 15 minute after giving spinal anaesthesia, there after every 5 minutes.

To record APGAR score of the new born in recommended time afrer delivery.

To determine the time of requirement of first rescue analgesic

To find out incidence of side effets during the operative procedure & upto the requirement of rescue analgesic in both the group 
Every minute in first 15 minute after giving spinal anaesthesia, there after every 5 minutes. 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   15/09/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 considered a popular and well accepted technique for cesarean section. Hyperbaric bupivacaine is the most common local anesthetic used for spinal anesthesia in term pregnancy undergoing elective caesarean delivery. Levobupivacaine is relatively new long acting local anesthetic that has been produced to address the issue of cardio-vascular and neurological toxicity following inadvertent intravascular injection. The three-dimensional structure of local anesthetic molecules forms two different special configurations R+ and S- forms. The differential affinity of these enantiomers for sodium, potassium and calcium channels results in a significant reduction of neurological and cardiac toxicity of S-enantiomers in comparison of R enantiomers. With Bupivacaine, cardiotoxicity manifests as cardiac arrythmias and severe cardiac collapse that can be rapid irreversible and fatal. In caesarean section, onset as well as sensory and motor block is higher with levobupivacaine than Bupivacaine. Levobupivacaine is S (-) enantiomer which is recently introduced for obstetrics spinal and epidural anesthesia. It has more selective neuraxial blockage. Dexmedetomidine is a  α2 adrenergic receptor agonist , an imidazole derivative with the chemical name 4 [(1R)-1- (2,3- dimethyl phenyl) ethyl ] – 3H – imidazole hydrochloride. It exhibits synergism with local anaesthetics prolonging sensory and motor block, delaying the time to the first analgesic, and improving post operative analgesia. Dexmedetomidine is a highly selective activator of the α2 A receptor acting on the nucleolus of the nucleus, and it can have a sedative and hypnotic effects, while its action on the spinal cord can produce analgesic effects, while its action on the peripheral and CNS can play a role in inhibiting sympathetic excitation. NAAZ et. al, in their study “OPTIMAL DOSE OF INTRATHECAL DEXMEDETOMIDINE IN LOWER ABDOMINAL SURGERIES IN AVERAGE INDIAN ADULT”, concluded that 10 µgm of DEXMEDETOMIDINE has optimal action and 5µgm did not gave any sedating effect. YUN QI WANG et.al in their study “EFFECT OF INTRATHECAL DEXMEDETOMIDINE ON CAESARIAN SECTION DURING SPINAL ANAESTHESIA; A META ANALYSIS OF RANDAMISED TRIAL”, concluded, 5µgm dexmedetomidine decreases shivering and has no adverse effect on caesarian sections. Hence, we will compare effect of Levobupivacaine heavy with dexmedetomidine versus racemic bupivacaine heavy with dexmedetomidine in spinal anesthesia in cases of caesarean sections.

 
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