To compare and identify which medication among dexmedetomidine and fentanyl as additive to hyperbaric ropivacaine for spinal anaesthesia in patients undergoing removal of uterus surgery is safe and effective.

Comparing efficacy and safety of Intrathecal adjuvants Dexmedetomidine and Fentanyl with hyperbaric Ropivacaine in patients undergoing elective total abdominal hysterectomy surgery: A Randomized, Double-Blind, Clinical study. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064274

Enrollment

Registered

2024-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified

Interventions

Intervention1: intrathecal administration of adjuvants dexmedetomidine and fentanyl to hyperbaric ropivacaine: to compare the effect and safety of dexmedetomidine and fentanyl as an intrathecal adjuva

Eligibility

Inclusion criteria

Inclusion criteria: 1)patients belonging to ASA class I & class II. 2)patients without any severe comorbid diseases.

Exclusion criteria

Exclusion criteria: 1)Patients having any absolute contraindications for spinal anaesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac, respiratory, and CNS diseases. 2)Pregnant females and those with chronic diseases such as diabetes, hypertension,renal dysfunction, liver disorders and cardiac abnormalities. 3)Patients with body mass index >30 kg/m². 4)Patients shorter than 150 cm. 5)Patients allergic to any of the study drugs.

Design outcomes

Primary

Measure	Time frame
comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine.Timepoint: comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine at baseline,at 5 minutes, then every 15 minutes till end of the surgery, and in the postoperative period till blockade regression.	—

Measure

Time frame

comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine.Timepoint: comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine at baseline,at 5 minutes, then every 15 minutes till end of the surgery, and in the postoperative period till blockade regression.

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Secondary

Measure	Time frame
1)Complete sensory & motor blockade attained & time taken for the same. 2)Total duration of analgesia. 3)Rescue analgesia. 4)The haemodynamic changes such as hypotension & bradycardia. 5)Side effects such as pruritus, nausea & vomiting, shivering. Timepoint: 1)Complete sensory & motor blockade attained & time taken for the same at 5 minutes, then at every 15 minutes till blockade regression. 2)Total duration of analgesia in the postoperative period. 3)Rescue analgesia. 4)The haemodynamic changes such as hypotension & bradycardia occuring intraoperatively at every 15 minutes. 5)Side effects such as pruritus, nausea & vomiting, shivering occuring at the end of surgery.	—

Measure

Time frame

1)Complete sensory & motor blockade attained & time taken for the same. 2)Total duration of analgesia. 3)Rescue analgesia. 4)The haemodynamic changes such as hypotension & bradycardia. 5)Side effects such as pruritus, nausea & vomiting, shivering. Timepoint: 1)Complete sensory & motor blockade attained & time taken for the same at 5 minutes, then at every 15 minutes till blockade regression. 2)Total duration of analgesia in the postoperative period. 3)Rescue analgesia. 4)The haemodynamic changes such as hypotension & bradycardia occuring intraoperatively at every 15 minutes. 5)Side effects such as pruritus, nausea & vomiting, shivering occuring at the end of surgery.

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Countries

India

Contacts

Public ContactDr M Vivekanandh

karpaga vinayaga institute of medical sciences and research centre

vivu94unplugged@gmail.com9551403203

Outcome results

None listed

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