Comparison of effect of spinal Anaesthesia with two different drugs -Dexmedetomidine vs Fentanyl as additives to spinal Anaesthesia for Cesarean section

Comparative Study of Dexmedetomidine vs Fentanyl as Adjuvants to Intrathecal Bupivacaine in Cesarean Section A Randomized Double Blind Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080909

Enrollment

Registered

2025-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Comparative Study of block characteristics with Dexmedetomidine vs Fentanyl as Adjuvants to Intrathecal Bupivacaine for Cesarean Section: A Randomized, Double-Blind Clinical: Spinal ane

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA Il patients 2.Age: 20-40 years 3.Weight: more than 50 kgs 4.Term pregnant women planned for caesarean section 5.Living fetus 6.Intact amniotic membranes 7.No history of bleeding tendency

Exclusion criteria

Exclusion criteria: 1.Patient refusal. 2.Patients having known hypersensitivity to the drugs. 3. Age: less than 20 or more than40 years 4. Ill or more. 5.Weight: less than 50 kgs 6.Contraindication to spinal ana esthesia (coagulopathy, significant hypovolemia, systemic or local sepsis, increased intracranial pressure, local anesthetic or bupivacaine allergy). 7.High risk pregnancies as preeclampsia, CKD and any cardiac disorders 8.Chronic pain or daily intake of analgesic. 9. Abnormal placenta station e.g. placenta previa.

Design outcomes

Primary

Measure	Time frame
To compare onset and duration of sensory and motor blockade. Timepoint: 7 hours	—

Secondary

Measure	Time frame
To compare the regression of motor blockade to S1. To assess and compare the haemodynamic parameters between both groups.To assess two segment sensory regression time. To assess post operative pain using Visual Analogue Score(VAS). Side effects if any. Apgar scores of the neonate at birth and after 5minutes. Timepoint: 12 hours	—

Countries

India

Contacts

Public ContactProfDrMerlin Shalini Ruth

Chettinad Health city

merlin5shalini@gmail.com9790983957

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026