A clinical comparative Study of Ropivacaine with Dexmedetomidine or Ropivacaine with Fentanyl as an adjuvant in Thoracic Epidural for patients undergoing abdominal surgeries.

A clinical comparative Study of Ropivacaine with Dexmedetomidine or Fentanyl as an adjuvant in Thoracic Epidural for patients undergoing abdominal surgeries.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061452

Enrollment

Registered

2024-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ropivacaine with Dexmedetomidine: Inj. Ropivacaine 0.75% 20ml added with inj. Dexmedetomidine 1mic./kg body weight administered once via Epidural route. Duration of surgery maximum of 3

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II patients undergoing elective abdominal surgeries.

Exclusion criteria

Exclusion criteria: 1. Age less than 25 years and more than 60 years. 2. Unwilling patients not giving consent for operation. 3. Emergency cases and cases of duration more than 3 hours. 4. ASA physical status class III or more. 5. Patients having known hypersensitivity to amide local anaesthetics and Dexmedetomidine. 6. Patients displaying sign and symptoms of systemic infection. 7. Patients having local infection in thoracic spinal region. 8. Patients with pre-existing Diabetes Mellitus, Hypertension, Ischaemic Heart Disease, COPD or any other major systemic illness. 9. Pre-existing CNS disorder-Epilepsy and raised intracranial tension. 10. Pre-existing respiratory disorder-COPD, Asthma, Chronic Bronchitis. 11. Severe renal, hepatic, cardiological, haematological, metabolic disorder. 12. Cardiovascular malformation. 13. Bleeding diathesis or coagulopathy. 14. Spinal deformity. 15. Patients on anticoagulant or antiplatelet therapy.

Design outcomes

Primary

Measure	Time frame
Postoperative analgesia with Duration of analgesiaTimepoint: From time of insertion of epidural and drug given till the time patient starts complaining pain.	—

Secondary

Measure	Time frame
1. Intraoperative Haemodynamic status: HR, BP (MAP), SpO2. 2. Duration of sensory block. 3. Duration of motor block. 4. Time of rescue analgesia. 5. Complications. Timepoint: 1. Intraoperative Haemodynamic status like HR, BP (MAP), SpO2 are measured every 1 minute for first 5 minutes, then every 5 minutes for next 15 minutes,after that every 10 minutes for next 40 minutes & lastly every 20 minutes till the end of the surgery. 2. Duration of sensory block & Duration of motor block is from drug given till patient complaint of sensation & motor power. 4. Time of rescue analgesia means time when patient required any pain medication. 5. Complications.	—

Measure

Time frame

1. Intraoperative Haemodynamic status: HR, BP (MAP), SpO2. 2. Duration of sensory block. 3. Duration of motor block. 4. Time of rescue analgesia. 5. Complications. Timepoint: 1. Intraoperative Haemodynamic status like HR, BP (MAP), SpO2 are measured every 1 minute for first 5 minutes, then every 5 minutes for next 15 minutes,after that every 10 minutes for next 40 minutes & lastly every 20 minutes till the end of the surgery. 2. Duration of sensory block & Duration of motor block is from drug given till patient complaint of sensation & motor power. 4. Time of rescue analgesia means time when patient required any pain medication. 5. Complications.

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Countries

India

Contacts

Public ContactPrashant Singh

L.L.R.M. Medical College, Meerut.

dr.yogeshkmanik@gmail.com9634857368

Outcome results

None listed

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