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Postoperative PainNCT05772832

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

An observational study of Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Postoperative Pain
What is being tested?
Dexmedetomidine and Remifentanyl
Type of treatment
Injection or infusion
How many people
104 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Nov 2021to 22 Feb 2023
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients undergoing transsphenoidal pituitary surgery

Who may be able to join

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

Who cannot join

  • Patients in need of postoperative intensive care

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • University of Kocaeli

    Kocaeli, IZMIT

Other trials in Turkey (Türkiye)

About this study

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. .

Being tested
Dexmedetomidine, Remifentanyl
Keywords
DEXMEDETOMİDİNE, REMİFENTANYL, pituitary SURGERY
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Efficacy of dexmedetomidine on postoperative pain in patients undergoing transsphenoidal pituitary surgery

  • RemifentanylDrug

    Efficacy of remifentanyl on postoperative pain in patients undergoing transsphenoidal pituitary surgery

Study groups in NCT05772832
Study groupRoleWhat they receive
GROUP USING REMIFENTANYLTHE 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
Receives: Drug: Remifentanyl
GROUP USING DEXMEDETOMIDINETHE 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
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative pain scale

    Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )

    Measured: at post anesthesia care unit (T1)

  2. postoperative pain scale

    Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )

    Measured: 2 hours after surgery (T2)

  3. postoperative pain scale

    Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )

    Measured: 8 hours after surgery (T3)

  4. postoperative pain scale

    Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )

    Measured: 24 hours after surgery (T4)

Secondary outcomes (8)

  1. need for analgesics

    Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication

    Measured: Additional analgesic drug requirements at post anesthesia care unit (T1)

  2. need for analgesics

    Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication

    Measured: Additional analgesic drug requirements at 2 hours after surgery (T2)

  3. need for analgesics

    Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication

    Measured: Additional analgesic drug requirements at 8 hours after surgery (T3)

  4. need for analgesics

    Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication

    Measured: Additional analgesic drug requirements at 24 hours after surgery (T4)

  5. Comparison of postoperative nausea-vomiting rate

    Comparison of postoperative nausea-vomiting rate

    Measured: at post anesthesia care unit (T1)

  6. Comparison of postoperative nausea-vomiting rate

    Comparison of postoperative nausea-vomiting rate

    Measured: 2 hours after surgery (T2)

  7. Comparison of postoperative nausea-vomiting rate

    Comparison of postoperative nausea-vomiting rate

    Measured: 8 hours after surgery (T3)

  8. Comparison of postoperative nausea-vomiting rate

    Comparison of postoperative nausea-vomiting rate

    Measured: 24 hours after surgery (T4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start17 Nov 2021
  3. Primary completion14 Dec 2022
  4. Study completion22 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
104 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772832
Sponsor's protocol ID
KocaeliUI
Status last verified
Aug 2025
First submitted
18 Feb 2023
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zheng Y, Cui S, Liu Y, Zhang J, Zhang W, Zhang J, Gu X, Ma Z. Dexmedetomidine prevents remifentanil-induced postoperative hyperalgesia and decreases spinal tyrosine phosphorylation of N-methyl-d-aspartate receptor 2B subunit. Brain Res Bull. 2012 Mar 10;87(4-5):427-31. doi: 10.1016/j.brainresbull.2012.01.009. Epub 2012 Jan 25.

    PubMed 22301064

  • Lee C, Kim YD, Kim JN. Antihyperalgesic effects of dexmedetomidine on high-dose remifentanil-induced hyperalgesia. Korean J Anesthesiol. 2013 Apr;64(4):301-7. doi: 10.4097/kjae.2013.64.4.301. Epub 2013 Apr 22.

    PubMed 23646238

  • Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31.

    PubMed 11056756

  • Virtanen R, Savola JM, Saano V, Nyman L. Characterization of the selectivity, specificity and potency of medetomidine as an alpha 2-adrenoceptor agonist. Eur J Pharmacol. 1988 May 20;150(1-2):9-14. doi: 10.1016/0014-2999(88)90744-3.

    PubMed 2900154

  • Hwang W, Lee J, Park J, Joo J. Dexmedetomidine versus remifentanil in postoperative pain control after spinal surgery: a randomized controlled study. BMC Anesthesiol. 2015 Feb 24;15:21. doi: 10.1186/s12871-015-0004-1. eCollection 2015.

    PubMed 25750586

  • Javaherforooshzadeh F, Monajemzadeh SA, Soltanzadeh M, Janatmakan F, Salari A, Saeed H. A Comparative Study of the Amount of Bleeding and Hemodynamic Changes between Dexmedetomidine Infusion and Remifentanil Infusion for Controlled Hypotensive Anesthesia in Lumbar Discopathy Surgery: A Double-Blind, Randomized, Clinical Trial. Anesth Pain Med. 2018 Apr 28;8(2):e66959. doi: 10.5812/aapm.66959. eCollection 2018 Apr.

    PubMed 30009153

  • Rajan S, Hutcherson MT, Sessler DI, Kurz A, Yang D, Ghobrial M, Liu J, Avitsian R. The Effects of Dexmedetomidine and Remifentanil on Hemodynamic Stability and Analgesic Requirement After Craniotomy: A Randomized Controlled Trial. J Neurosurg Anesthesiol. 2016 Oct;28(4):282-90. doi: 10.1097/ANA.0000000000000221.

    PubMed 26325514

  • Choi EK, Seo Y, Lim DG, Park S. Postoperative nausea and vomiting after thyroidectomy: a comparison between dexmedetomidine and remifentanil as part of balanced anesthesia. Korean J Anesthesiol. 2017 Jun;70(3):299-304. doi: 10.4097/kjae.2017.70.3.299. Epub 2017 Mar 15.

    PubMed 28580080

  • Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Colectomy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Medicine (Baltimore). 2015 Oct;94(43):e1727. doi: 10.1097/MD.0000000000001727.

    PubMed 26512563

  • Salman N, Uzun S, Coskun F, Salman MA, Salman AE, Aypar U. Dexmedetomidine as a substitute for remifentanil in ambulatory gynecologic laparoscopic surgery. Saudi Med J. 2009 Jan;30(1):77-81.

    PubMed 19139778

  • Hamed JME, Refaat HSM, Al-Wadaani H. Dexmedetomidine Compared to Remifentanil Infusion as Adjuvant to Sevoflurane Anesthesia during Laparoscopic Sleeve Gastrectomy. Anesth Essays Res. 2019 Oct-Dec;13(4):636-642. doi: 10.4103/aer.AER_126_19. Epub 2019 Dec 16.

    PubMed 32009708

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pain scale (time frame: at post anesthesia care unit (T1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772832, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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