Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study (Effects of Dex)

November 17, 2023 updated by: Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Effects of Dexmetomidine
Patients in this group will be given dexmedetomidine infusion during the intraoperative period to provide controlled hypotension.
Drug: Dexmedetomidine
After the induction of general anesthesia, one group (Group: 1) will be administered dexmedotomidin infizyon and group (Group :2)remifentanil
Active Comparator: Effects of Remifentanil
Patients in this group will be given remifentanil infusion during the intraoperative period to provide controlled hypotension.
Drug: Remifentanil
Remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iceb
Time Frame: preoperative and postoperative (immediatly after extubation)
Qt\Qrs
preoperative and postoperative (immediatly after extubation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Riker Agitation Scale
Time Frame: Immediately after extubation
7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable
Immediately after extubation
mean arterial pressure
Time Frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
mmHg
when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
heart rate
Time Frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
beats\minute
when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
Numeric Rating Scale
Time Frame: Postoperative 0-2 hours
They will be numbered from 1 to 10. 1 mildest 10 most severe pain
Postoperative 0-2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTosun

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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