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

Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06138574
Collaborator
(none)
72
2
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. iceb [preoperative and postoperative (immediatly after extubation)]

    Qt\Qrs

Secondary Outcome Measures

  1. Riker Agitation Scale [Immediately after extubation]

    7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable

  2. mean arterial pressure [when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion]

    mmHg

  3. heart rate [when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion]

    beats\minute

  4. Numeric Rating Scale [Postoperative 0-2 hours]

    They will be numbered from 1 to 10. 1 mildest 10 most severe pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hülya Tosun Söner, HTosunSoner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06138574
Other Study ID Numbers:
  • HTosun
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023