Cognitive Functions After TIVA With Dexmedetomidine

NCT02631135 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-17

Study results available
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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

Interventions

DRUG

Remifentanil

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

DRUG

Propofol

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

DRUG

Dexmedetomidine

0.5 microgram/kg infusion, no changes

DRUG

Rocuronium

0.5 mg/kg iv for intubation, no changes

Sponsors & Collaborators

  • Uludag University

    lead OTHER

Principal Investigators

  • Hulya Bilgin, professor · Uludag University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-10-31
Completion
2008-10-31
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631135 on ClinicalTrials.gov