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
|
|
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
|
|
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 ADULTâ€, 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 TRIALâ€, 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. |