Cognitive Functions After TIVA With Dexmedetomidine

NCT02631135 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2007-21/18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

It is important to wake up without any problem and comfortably from the general anesthesia. The aim of this study is to investigate the effects of addition dexmedetomidine to the balanced intravenous anesthesia with propofol over the cognitive functions and also it is considered that the addition of dexmedetomidine would reduce the use of anesthetics drugs in TİVA. Together with this effects, it has been considered that the disorder of the cognitive functions in postoperative period and the need for anesthetic drugs in postoperative period will be less. After the approval of the Ethics Committee and the patients being informed and taking informed consent from them 18 female 23 male totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients have been divided into two groups by closed envelope drawing method, randomly. All patients cognitive functions were evaluated by MMSE (Mini Mental State Examination) during the premedication visit. For this study group Standardized Mini Mental Test Examination (SMMT-E) were used, which has quite practical usage, for the untrained patients, and test composed of question-answer in order to calculate the remembering, caution and calculation structure and the scores were recorded. All patients had received the same anesthesia induction with propofol infusion (started at firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS(bispectral index) values were arranged between 40-60 until the end of the operation), and remifentanil infusion (0.5 μg.kg-1 was applied as opioid and was arranged according to the tension artery and heart rate). In the dexmedetomidine group, dexmedetomidine infusion had started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for the endotracheal intubation. After the operation all patients have taken to the recovery room. Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24 hours, 1 week and 1 month.

Conditions

Postoperative Confusion

Keywords

Dexmedetomidine; cognitive functions; MMSE

Outcome Measures

Primary Outcomes (4)

• Mini Mental State Examination (MMSE) Score at the Second Hour After Surgery

  The cognitive function evaluation performed by MMSE test at the second hour of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions

  Postoperative hour 2

• Mini Mental State Examination (MMSE) Score at the First Month After Surgery

  The cognitive function evaluation performed by MMSE test at the one month of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions

  Postoperative month one

• Mini Mental State Examination (MMSE) Score at the First Week After Surgery

  The cognitive function evaluation performed by MMSE test at the one week of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions

  postoperative week one

• Mini Mental State Examination (MMSE) Score at the 24th Hour After Surgery

  The cognitive function evaluation performed by MMSE test at the 24th hour of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions

  Postoperative hour 24

Study Arms (2)

Group 1 (TIVA)

PLACEBO COMPARATOR

Only propofol (started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1) and rocuronium for intubation

Drug: Remifentanil; Drug: Propofol; Drug: Rocuronium

Group 2 (TIVA+D)

ACTIVE COMPARATOR

Propofol started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1),and also dexmedetomidine infusion (started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made during the operation) and rocuronium for intubation

Drug: Remifentanil; Drug: Propofol; Drug: Dexmedetomidine; Drug: Rocuronium

Interventions

Remifentanil DRUG

In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased

Also known as: ultiva

Group 1 (TIVA); Group 2 (TIVA+D)

Propofol DRUG

BIS values were arranged 40-60 until the end of operation

Group 1 (TIVA); Group 2 (TIVA+D)

Dexmedetomidine DRUG

0.5 microgram/kg infusion, no changes

Also known as: precedex

Group 2 (TIVA+D)

Rocuronium DRUG

0.5 mg/kg iv for intubation, no changes

Also known as: esmeron

Group 1 (TIVA); Group 2 (TIVA+D)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• under going lumbar disk hernia operation
• years old
• ASA (American Society of Anesthesiologists Physical Status classification) classification I-II

You may not qualify if:

• pregnants
• Patients with hepatic, renal or neurological diseases and
• patients using sedative- hypnotic, anticonvulsive and stimulant drugs
• One of the patient excluded from the study (can not be able to reached after surgery)

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University

Bursa, Turkey (Türkiye)

Location

Related Publications (5)

• Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.

  PMID: 9447431 BACKGROUND

• Magni G, Baisi F, La Rosa I, Imperiale C, Fabbrini V, Pennacchiotti ML, Rosa G. No difference in emergence time and early cognitive function between sevoflurane-fentanyl and propofol-remifentanil in patients undergoing craniotomy for supratentorial intracranial surgery. J Neurosurg Anesthesiol. 2005 Jul;17(3):134-8. doi: 10.1097/01.ana.0000167447.33969.16.

  PMID: 16037733 BACKGROUND

• Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.

  PMID: 16803911 BACKGROUND

• Weinbroum AA, Geller E. Flumazenil improves cognitive and neuromotor emergence and attenuates shivering after halothane-, enflurane- and isoflurane-based anesthesia. Can J Anaesth. 2001 Nov;48(10):963-72. doi: 10.1007/BF03016585.

  PMID: 11698314 RESULT

• Kostopanagiotou G, Markantonis SL, Polydorou M, Pandazi A, Kottis G. Recovery and cognitive function after fentanyl or remifentanil administration for carotid endarterectomy. J Clin Anesth. 2005 Feb;17(1):16-20. doi: 10.1016/j.jclinane.2004.03.008.

  PMID: 15721724 RESULT

MeSH Terms

Interventions

Remifentanil; Propofol; Dexmedetomidine; Rocuronium

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The examined subject number was small The evaluation of cognitive function was made by one test which is very associate with the participants education level

Results Point of Contact

• Title: Hale Aksu Erdost,MD,spesialist
• Organization: UludagU

haleaksu78@yahoo.com

+905323615722

Study Officials

• Hulya Bilgin, professor

  Uludag University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 16, 2015
• Study Start: January 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 17, 2024
• Results First Posted: May 17, 2024

Record last verified: 2020-08

Locations

TU (1)