Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.

• Sponsor: Sheikh Zayed Medical College (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05311722
• Collaborator: (none)
• Enrollment: 71
• Arms: 3
• Anticipated Duration (Months): 9.7

Study Details

Study Description

Brief Summary

To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine

Condition or Disease	Intervention/Treatment	Phase
Post-Surgical Complication	Drug: Dexmedetomidine; Drug: Ketamine; Drug: Tramadol	Phase 3

Detailed Description

Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent cesarean section.using grades of shivering (0-4)patients will be assessed

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 3 drugs were given to patients3 drugs were given to patients
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section
• Anticipated Study Start Date: Apr 30, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine Inj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes	Drug: Dexmedetomidine; Inj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed.
Experimental: Ketamine Inj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes	Drug: Ketamine; Ketamine
Experimental: Tramadol Inj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes	Drug: Tramadol; Tramadol

Outcome Measures

Primary Outcome Measures

1. Assessment of post spinal shivering by observing grades of shivering [10 minutes]

   Control of post spinal shivering dexmedetomidine, tramadol and ketamine for control of post spinal shivering.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Woman of age 18-60

• Pregnant woman in outdoor patient department and emergency

Exclusion Criteria:

• patient. with history of hypersensitivity to opioids,

• ketamine or bupivacaine

• History of cardiovascular disease,

• Hypertension,

• psychosis,

• antepartum hemorrhage,

• cord prolapse,

• fetal distress

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sheikh Zayed Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Obaid ur Rehman, Principal investigator, Sheikh Zayed Medical College
• ClinicalTrials.gov Identifier: NCT05311722
• Other Study ID Numbers: ORehman
• First Posted: Apr 5, 2022
• Last Update Posted: Apr 5, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexmedetomidine; Ketamine; Tramadol

Study Results

No Results Posted as of Apr 5, 2022