Comparison of effects of dexmedetomidine added to levobupivacaine and recemic bupivacaine for cesarean section under spinal anaesthesia.

Phase 4

Not yet recruiting

Conditions: Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2023/09/057280

Lead Sponsor: Rajendra Insitute of Medical Sciences, Ranchi

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 Î±2 adrenergic receptor agonist , an imidazole derivative with the chemical name 4 [(1R)-1- (2,3- dimethyl phenyl) ethyl ] â€“ 3H â€“ 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 Î±2 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 â€œOPTIMAL DOSE OF INTRATHECAL DEXMEDETOMIDINE IN LOWER ABDOMINAL SURGERIES IN AVERAGE INDIAN ADULTâ€, concluded that 10 Âµgm of DEXMEDETOMIDINE has optimal action and 5Âµgm did not gave any sedating effect. YUN QI WANG et.al in their study â€œEFFECT OF INTRATHECAL DEXMEDETOMIDINE ON CAESARIAN SECTION DURING SPINAL ANAESTHESIA; A META ANALYSIS OF RANDAMISED TRIALâ€, concluded, 5Âµgm 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 130

Inclusion Criteria

The patient giving informed and written consent for study.
Primigravida posted for elective caesarean section with more than 37 weeks gestation.
Having singleton pregnancy.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Rajendra Insitute of Medical Sciences, Ranchi
🇮🇳
Ranchi, JHARKHAND, India
Rajendra Insitute of Medical Sciences, Ranchi
🇮🇳Ranchi, JHARKHAND, India
Dr Archana
Principal investigator
7033626390
archanakamal1972@gmail.com