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

NCT05481281 | Unknown Phase 3

• 1 other identifier: N0331
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chills

Keywords

spinal anesthesia; vaginal hysterectomy; shivering

Outcome Measures

Primary Outcomes (1)

• Change in Shivering grade

  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.

  Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively

Study Arms (2)

Group Dexmedetomidine

EXPERIMENTAL

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

Group Ketamine

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion

Group Dexmedetomidine

Ketamine DRUG

0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion

Group Ketamine

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: female aged b/w 45-55years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of age 45-55 years requiring vaginal hysterectomy
• American Society of Anesthesiology (ASA) of Grade I-II

You may not qualify if:

• Patients unwilling or non-cooperative for spinal anesthesia
• Patients with uncontrolled hypertension, vascular or coronary disease,
• patients with increased intraocular or intracranial pressure
• Patients with known bleeding and psychiatric disorders
• Patients taking anti platelets drugs.

Sponsors & Collaborators

• Hamdard University: lead

MeSH Terms

Conditions

Chills

Interventions

Dexmedetomidine; Ketamine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nida Shahid, MBBS,FCPS

  Hamdard University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nida Shahid, MBBS, FCPS

CONTACT

+923332358698; nida-shahid2011@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 1, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 31, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share