COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY

August 20, 2025 updated by: İpek İZGİN AVCI, Kocaeli University
In patients with pituitary adenoma scheduled for endoscopic transsphenoidal pituitary surgery, it was aimed to compare the efficacy of postoperative pain relief of a selective α-2 agonist "Dexmedetomidine" and the rapid and short-acting opioid "Remifentanil" using the "Numerical Rating Scale" (NRS) administered alongside propofol in perioperative maintenance anesthesia. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients undergoing transsphenoidal pituitary surgery

Description

Inclusion Criteria:

  • 18-65 years old
  • ASA-1 and ASA-2 patients

Exclusion Criteria:

  • Patients in need of postoperative intensive care

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GROUP USING REMIFENTANYL
THE GROUP USING PEROPERATIVE REMIFENTANYL AND PROPOFOL IN TRANSSPHENOIDAL Pituitary Surgery 0.01-0.2 μg /kg /min Remifentanyl and 3-12 mg/kg/h propofol
Drug: Remifentanyl
Efficacy of remifentanyl on postoperative pain in patients undergoing transsphenoidal pituitary surgery
GROUP USING DEXMEDETOMIDINE
THE GROUP USING PEROPERATIVE DEXMEDETOMIDINE AND PROPOFOL IN TRANSSPHENOIDAL Pituitary Surgery 0.01-0.02 μg/kg/min (~0.5 μg/kg/h) continuous infusion of dexmedetomidine 1 mcg/kg 10 minutes after a loading dose and 3-12 mg/kg/h propofol
Drug: Dexmedetomidine
Efficacy of dexmedetomidine on postoperative pain in patients undergoing transsphenoidal pituitary surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain scale
Time Frame: at post anesthesia care unit (T1)
Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )
at post anesthesia care unit (T1)
postoperative pain scale
Time Frame: 2 hours after surgery (T2)
Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )
2 hours after surgery (T2)
postoperative pain scale
Time Frame: 8 hours after surgery (T3)
Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )
8 hours after surgery (T3)
postoperative pain scale
Time Frame: 24 hours after surgery (T4)
Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )
24 hours after surgery (T4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for analgesics
Time Frame: Additional analgesic drug requirements at post anesthesia care unit (T1)
Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication
Additional analgesic drug requirements at post anesthesia care unit (T1)
need for analgesics
Time Frame: Additional analgesic drug requirements at 2 hours after surgery (T2)
Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication
Additional analgesic drug requirements at 2 hours after surgery (T2)
need for analgesics
Time Frame: Additional analgesic drug requirements at 8 hours after surgery (T3)
Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication
Additional analgesic drug requirements at 8 hours after surgery (T3)
need for analgesics
Time Frame: Additional analgesic drug requirements at 24 hours after surgery (T4)
Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication
Additional analgesic drug requirements at 24 hours after surgery (T4)
Comparison of postoperative nausea-vomiting rate
Time Frame: at post anesthesia care unit (T1)
Comparison of postoperative nausea-vomiting rate
at post anesthesia care unit (T1)
Comparison of postoperative nausea-vomiting rate
Time Frame: 2 hours after surgery (T2)
Comparison of postoperative nausea-vomiting rate
2 hours after surgery (T2)
Comparison of postoperative nausea-vomiting rate
Time Frame: 8 hours after surgery (T3)
Comparison of postoperative nausea-vomiting rate
8 hours after surgery (T3)
Comparison of postoperative nausea-vomiting rate
Time Frame: 24 hours after surgery (T4)
Comparison of postoperative nausea-vomiting rate
24 hours after surgery (T4)

Collaborators and Investigators

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

Sponsor

Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 17, 2021

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

February 22, 2023

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KocaeliUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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