Comparison Of Dexmedetomidine & Ketamine For Control Of Shivering In Vaginal Hysterectomy Under Spinal Anesthesia

• Sponsor: Hamdard University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05481281
• Collaborator: (none)
• Enrollment: 104
• Arms: 2
• Anticipated Duration (Months): 6

Study Details

Study Description

Brief Summary

comparison of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Chills	Drug: Dexmedetomidine; Drug: Ketamine	Phase 3

Detailed Description

In this study the participants aim to Compare Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomly assigned to either group Dexmedetomidine (receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion) OR group Ketamine (receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion) through sequentially numbered opaque sealed envelope. Anesthesiologist and patients both will be blinded to the administered drug in two groups. Either of the drugs will be injected after giving spinal anesthesia and confirmation of achievement of desired level of block. In the recovery room Shivering grade, and vitals of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively. 1st reading taken 15minutes after giving the drug will be labelled as Zero time.Patients will be randomly assigned to either group Dexmedetomidine (receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion) OR group Ketamine (receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion) through sequentially numbered opaque sealed envelope. Anesthesiologist and patients both will be blinded to the administered drug in two groups. Either of the drugs will be injected after giving spinal anesthesia and confirmation of achievement of desired level of block. In the recovery room Shivering grade, and vitals of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively. 1st reading taken 15minutes after giving the drug will be labelled as Zero time.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: the drugs will be prepared by anesthesiologist who will not be the part of the study and these drugs will be injected by another anesthesiologist who will be blinded to the drugs and will be participating into the study.
• Primary Purpose: Treatment
• Official Title: Comparison Of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Dexmedetomidine Group Dexmedetomidine receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion	Drug: Dexmedetomidine; I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion
Experimental: Group Ketamine Group Ketamine receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion	Drug: Ketamine; 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion

Outcome Measures

Primary Outcome Measures

1. Change in Shivering grade [Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively]

   Shivering of patients will be grouped into five grades; Grade 0: lack of shivering, Grade I: slight shivering (inconsiderable yet apparent peripheral vasoconstriction), Grade II: medium level shivering (muscular activity in one muscle group only), Grade III: severe shivering (muscular activity in more than one muscle group without generalized shivering), Grade IV: generalized shivering.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Patients of age 45-55 years requiring vaginal hysterectomy

2. American Society of Anesthesiology (ASA) of Grade I-II

Exclusion Criteria:

1. Patients unwilling or non-cooperative for spinal anesthesia

2. Patients with uncontrolled hypertension, vascular or coronary disease,

3. patients with increased intraocular or intracranial pressure

4. Patients with known bleeding and psychiatric disorders

5. Patients taking anti platelets drugs.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hamdard University

Investigators

• Principal Investigator: Nida Shahid, MBBS,FCPS, Hamdard University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Nida Shahid, Assistant Professor, Anesthesiology, Hamdard University
• ClinicalTrials.gov Identifier: NCT05481281
• Other Study ID Numbers: N0331
• First Posted: Aug 1, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 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
• Keywords provided by Dr. Nida Shahid, Assistant Professor, Anesthesiology, Hamdard University: spinal anesthesia; vaginal hysterectomy; shivering
• Additional relevant MeSH terms: Dexmedetomidine; Ketamine

Study Results

No Results Posted as of Aug 1, 2022