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A clinical trail to study the effect of intrathecal Dexmeditomidine with Magnesium sulphate as an additional adjuvant to intrathecal Morphine and Bupivacaine combination for post operative analgesia in patients undergoing major abdominal surgeries.

Comparison of Dexmedetomidine with Magnesium sulphate as an additional adjuvant to intrathecal Bupivacaine and Morphine combination for post operative analgesia in patients undergoing major abdominal Surgeries. A Prospective randomized double blind study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063906
Enrollment
60
Registered
2024-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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: Intrathecal Morphine 200 mcg + 0.5% Hyperbaric Bupivacaine 5mg + Dexmeditomidine 5mcg stat dose after surgery.: These drugs are given intrathecally after completion of surgery for post

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients Aged 18-65years. 2.Patients belonging to American society of anaesthesiologists (ASA PS) physical status grade I, II and III . 3.Patients scheduled to undergo major abdominal surgeries with expected duration of 3 to 4 hrs and 4.Patients willing to give the written consent to participate in the study will be included in the study.

Exclusion criteria

Exclusion criteria: Patients who are not willing to participate in the study. Patients with history of intolerance or showing anaphylactic reaction to the medications used in the study. Patients with severe hepatic, renal, cardiac and neurological disorders. Pregnant and lactating women. Patients who cannot understand or interpret VAS for pain assessment and Patients who could not be positioned for regional technique post-surgery will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the total morphine consumption between two groups in the first 24 hrs and second 24 hrs following surgery.Timepoint: 24hrs and 48hrs

Secondary

MeasureTime frame
1.To assess the magnitude of pain by visual analogue Scale (VAS) at different points of time. 2.To assess sensory block by Hollmen scale. 3.To assess motor block by Bromage scale. 4.To find out time of first request of rescue analgesic between two groups. 5.To assess the time after which patient can do deep breathing exercises with the help of an incentive spirometer. 6.To assess incidence of side effects and complications (Nausea, Vomiting, pruritis postoperative respiratory depression, hemodynamic disturbances, sedation, sensory and motor block). 7.To assess the length of High dependency unit (HDU ) stay (ward worthiness). 8.To assess the overall patient’s satisfaction by visual analogue score. 9.Post operative sedation score will be assessed by Ramsay sedation score (RSS). Timepoint: hourly in first 6hrs and then every 6hrs for 48 hrs

Countries

India

Contacts

Public ContactDr MALOTH RAJENDRA PRASAD

Sri venkateswara institute of Medical sciences

subhadrapeyyety@gmail.com9490573073

Outcome results

None listed

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