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

NCT05772832 | Completed FDA Drug

• 1 other identifier: KocaeliUI
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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 alongside propofol in perioperative maintenance anesthesia. .

Conditions

Postoperative Pain

Keywords

DEXMEDETOMİDİNE; REMİFENTANYL; pituitary SURGERY

Outcome Measures

Primary Outcomes (4)

• postoperative pain scale

  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

  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

  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

  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 Outcomes (8)

• need for analgesics

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

• need for analgesics

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

• need for analgesics

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

• need for analgesics

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

• Comparison of postoperative nausea-vomiting rate

  at post anesthesia care unit (T1)

Study Arms (2)

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

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

Interventions

Dexmedetomidine DRUG

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

GROUP USING DEXMEDETOMIDINE

Remifentanyl DRUG

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

GROUP USING REMIFENTANYL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing transsphenoidal pituitary surgery

You may qualify if:

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

You may not qualify if:

• Patients in need of postoperative intensive care

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

University of Kocaeli

Kocaeli, IZMIT, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 22301064 BACKGROUND

• 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.

  PMID: 23646238 BACKGROUND

• 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.

  PMID: 11056756 BACKGROUND

• 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.

  PMID: 2900154 BACKGROUND

• 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.

  PMID: 25750586 BACKGROUND

• 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.

  PMID: 30009153 BACKGROUND

• 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.

  PMID: 26325514 BACKGROUND

• 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.

  PMID: 28580080 BACKGROUND

• 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.

  PMID: 26512563 BACKGROUND

• 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.

  PMID: 19139778 BACKGROUND

• 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.

  PMID: 32009708 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 16, 2023
• Study Start: November 17, 2021
• Primary Completion: December 14, 2022
• Study Completion: February 22, 2023
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

TU (1)