Heavy ropivacaine with and without dexmedetomidine as an adjuvant in spinal anaesthesia for caesarean section

Not yet recruiting

• Conditions: Certain conditions originating in the perinatal period,

• Registration Number: CTRI/2023/11/059631
• Lead Sponsor: Mohammadfaizan kanuga

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-11
• Study Start: 2023-11-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Onset and duration of sensory &motor blockade	24 hours
2)Duration of post operative analgesia and 24 hours analgesic requirement	24 hours

Secondary Outcome Measures

Name	Time	Method
1)Hemodynamic parameters	2)Adverse effects and side effects

Trial Locations

Locations (1)

Government medical college and new civil hospital; 🇮🇳 Surat, GUJARAT, India

Government medical college and new civil hospital

🇮🇳Surat, GUJARAT, India

Dr Mohammadfaizan Kanuga

Principal investigator

9913926780

kfaizangmers@gmail.com