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To compare the effect of Fentanyl and Dexmedetomidine when added to bupivacaine in Spinal Anaesthesia

EFFECT OF ADDING DEXMEDETOMIDINE VERSUS FENTANYL TO INTRATHECAL BUPIVACAINE ON SPINAL BLOCK CHARACTERISTICS IN GYNAECOLOGICAL PROCEDURES: A DOUBLE BLIND CONTROLLED STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/06/003755
Enrollment
60
Registered
2013-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Elective Gynaecological Surgeries

Interventions

Intervention1: Bupivacaine with Dexmedetomidine: Dose -2cc 0.5%(Heavy) bupivacaine (10mg ) + 5µg Dexmedetomidine in 0.5 cc preservative free solution Frequency -single shot Route -Intrathecal Control

Sponsors

Govt Medical College Trivandrum
Lead Sponsor
Dr Nikhil Nandan
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: ASA I / II / III of ASA physical status classification. Height 155 to 175 cm

Exclusion criteria

Exclusion criteria: Patients having drug allergy to local anaesthetics. Those with anatomical abnormalities of the spine, peripheral neuropathy, bleeding disorders or anticoagulation therapy. Patients with serious systemic illness, psychiatric illness, mental retardation.

Design outcomes

Primary

MeasureTime frame
Duration of analgesia in terms of time for onset of mild pain postoperatively visual analogue scale 4 and above or patient request for analgesiaTimepoint: Visual analogue scale assessed every 15 minutes till score reaches 4 and above or till the patient requests analgesia—

Secondary

MeasureTime frame
Need of additional analgesicTimepoint: Intraoperative;Peak sensory level reachedTimepoint: Intraoperative;Sedation produced by the two groupsTimepoint: Intraoperative every 15 minutes;Time for onset of adequate level of analgesia ( T10 level assessed by bilateral pin prick )Timepoint: Intraoperative;Time taken for motor block to recede to BromageTimepoint: Intraoperative and Postoperative;â?¢ Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groupsTimepoint: Intraoperative and Postoperative;Haemodynamic profile of the two groupsTimepoint: every minute for the first 20 minutes and every two-minute for the next 20 minutes and every five minutes till the end of surgery and then every 10-15 minutes for three hours post operatively—

Countries

India

Contacts

Public ContactDr NIKHIL NANDAN
linettemorris5@gmail.com

Outcome results

None listed

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