NCT05950555

Brief Summary

The primary aim of this study was to compare the effects of dexmedetomidine and ketamine, which are administered intravenously during surgery, on the levels of malondialdehyde, an antioxidant, anti-inflammatory enzyme, heme oxygenase-1 enzyme levels and C-reactive protein levels in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

June 5, 2023

Last Update Submit

August 29, 2023

Conditions

MalondialdehydeHeme OxygenaseC-Reactive Protein

Keywords

KetamineDexmedetomidineOxidative StressAntioxidant

Outcome Measures

Primary Outcomes (9)

  • Concentration of Malondialdehyde

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.

    just before surgery

  • Heme Oxygenase-1

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.

    just before surgery

  • C-Reactive Protein

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.

    just before surgery

  • Malondialdehyde

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.

    2 hours after the start of surgery

  • Heme Oxygenase-1

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.

    2 hours after the start of surgery

  • C-Reactive Protein

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.

    2 hours after the start of surgery

  • Malondialdehyde

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.

    24 hours after surgery

  • Heme Oxygenase-1

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.

    24 hours after surgery

  • C-Reactive Protein

    The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.

    24 hours after surgery

Study Arms (3)

Patients given saline

ACTIVE COMPARATOR

10 cc/hour isotonic is given throughout the operation.

Other: Saline

Patients given dexmedetomidine.

ACTIVE COMPARATOR

Dexmedetomidine 0.1 µg/kg IV bolus followed by 0.2 µg/kg/hr infusion throughout surgery.

Other: Dexmedetomidine

Patients given ketamine.

ACTIVE COMPARATOR

Ketamine 0.2 mg/kg bolus followed by 0.1 mg/kg/hr infusion throughout surgery.

Other: Ketamine

Interventions

SalineOTHER

We used 0.9% isotonic sodium chloride.

Patients given saline
DexmedetomidineOTHER

We used the vial containing 200 mcg/2 ml i.v. concentrated infusion solution in 100 ml of 0.9% isotonic sodium chloride.

Patients given dexmedetomidine.
KetamineOTHER

We used 500 mg/10 ml solution for injection in 0.9% isotonic sodium chloride.

Patients given ketamine.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA risk classification 1-2
  • Patients who agreed to participate in the study

You may not qualify if:

  • Body mass index (BMI) over 30 kg/m2
  • Patients who will use bone cement in the surgical procedure
  • Patients who will apply a tourniquet to the lower extremity
  • Patients with vascular and coronary disease
  • Patients with coagulation disorders that would prevent the application of CSEA
  • Patients with allergies to the drugs to be used in the study
  • Patients with increased head and intraocular pressure
  • Patients with psychiatric and neuromuscular disorders
  • Patients with multiple trauma
  • Patients who did not consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sodium ChlorideDexmedetomidineKetamine

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • İrfan Uç

    Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2023

First Posted

July 18, 2023

Study Start

December 30, 2021

Primary Completion

March 30, 2023

Study Completion

May 28, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

we will decide later.

Locations

TU(1)