NCT06138574

Brief Summary

Our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. We planned to compare the patients by recording preoperative and postoperative ECGs. We also planned to record the patients' intraoperative blood pressure, saturation, and pulse rate, rickeragitation scale, and vas score.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 14, 2023

Last Update Submit

November 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • iceb

    Qt\\Qrs

    preoperative and postoperative (immediatly after extubation)

Secondary Outcomes (4)

  • Riker Agitation Scale

    Immediately after extubation

  • mean arterial pressure

    when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion

  • heart rate

    when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion

  • Numeric Rating Scale

    Postoperative 0-2 hours

Study Arms (2)

Effects of Dexmetomidine

ACTIVE COMPARATOR

Patients in this group will be given dexmedetomidine infusion during the intraoperative period to provide controlled hypotension.

Drug: Dexmedetomidine

Effects of Remifentanil

ACTIVE COMPARATOR

Patients in this group will be given remifentanil infusion during the intraoperative period to provide controlled hypotension.

Drug: Remifentanil

Interventions

After the induction of general anesthesia, one group (Group: 1) will be administered dexmedotomidin infizyon and group (Group :2)remifentanil

Effects of Dexmetomidine

Remifentanil

Effects of Remifentanil

Eligibility Criteria

Age17 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with an ASA score of I and between the ages of 17-45 years, who were to undergo general anesthesia with sevofulurane were included in the study.

You may not qualify if:

  • Patients aged \<17 and \>45 years, patients with liver and/or kidney failure, obese patients (BMI \>30), trauma patients, ASA II-III-IV patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexmedetomidineRemifentanil

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HTosunSoner

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

February 1, 2024

Study Completion

March 30, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11