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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05481281
Enrollment
104
Registered
2022-08-01
Start date
2022-08-01
Completion date
2023-01-31
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chills

Keywords

spinal anesthesia, vaginal hysterectomy, shivering

Brief summary

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

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.

Interventions

DRUGDexmedetomidine

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

DRUGKetamine

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

Sponsors

Hamdard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.

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.

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Shivering gradeShivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperativelyShivering 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.

Contacts

Primary ContactNida Shahid, MBBS, FCPS
nida-shahid2011@hotmail.com+923332358698

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026