To compare the pain relief in patients after operation ,with different doses of Dexmedetomidine (a drug )as added drug to Bupivacaine given in spinal anaesthesia & Bupivacaine alone in Open Uterine surgeries

Phase 1/2

Not yet recruiting

• Conditions: Hypertrophy of uterus, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/09/057299
• Lead Sponsor: Jubilee Mission Medical College and Research Institute

Brief Summary

This study is being undertaken  to evaluate and compare the duration of postoperative analgesia with different doses of intrathecal  Dexmedetomidine , as adjuvant to  Bupivacaine  in Total  Abdominal  Hysterectomy surgeries , and their side effect profile ( As evidenced by Hypotension  and Bradycardia ).Dexmedetomidine 10 mcg was a better adjuvant compared to 5 mcg in terms of better post operative analgesia without increased incidence of side effects  when used as intrathecal adjuvant to Bupivacaine in subarachnoid block

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-09
• Study Start: 2023-09-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

ASA I & ASA II PATIENTS SCHEDULED TOTAL ABDOMINAL HYSTERECTOMY.

Exclusion Criteria

• Patients with baseline Heart rate < 60 or on Beta blockers / Alpha agonist.
• Patient refusal for study participation .
• Local infection at injection site.
• Presence of any coagulopathies or bleeding disorders or patients on anticoagulation.
• PRESENCE OF NEUROLOGICAL DEFICITS, PERIPHERAL NEUROPATHIES, MYOPATHIES, OR CHRONIC PAIN IN THE OPERATING LIMB.
• PATIENTS WITH KNOWN ALLERGY TO LOCAL ANAESTHETICS OR TO ANY STUDY DRUGS TO BE USED.
• HEMODYNAMICALLY COMPROMISED PATIENTS ALCOHOLIC/ PSYCHIATRIC/UNCOOPERATIVE PATIENTS PATIENTS WITH HEPATIC / RENAL OR CARDIOPULMONARY DISORDERS.
• PATIENTS LESS THAN 5 FEET HEIGHT.
• TOTAL ABDOMINAL HYSTERECTOMY TAKING > 3 HRS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dexmedetomidine 10 mcg was a better adjuvant compared to 5 mcg in terms of better post operative analgesia when used as intrathecal adjuvant to Bupivacaine in subarachnoid block	Post operative analgesia assessed every 6 hours after the requirement of first dose of analgesic

Secondary Outcome Measures

Name	Time	Method
Onset of sensory block	Onset of motor block

Trial Locations

Locations (1)

Jubilee Mission Medical College and Research Institute; 🇮🇳 Thrissur, KERALA, India

Jubilee Mission Medical College and Research Institute

🇮🇳Thrissur, KERALA, India

Dr Kavya T

Principal investigator

8281958083

kavuz57t@gmail.com