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Completed

NCT Number: NCT02631135

Cognitive Functions After TIVA With Dexmedetomidine

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Uludag University

Bursa, Turkey (Türkiye)

About this study

After the approve of the Ethics Committee and the patients were informed and taken informed consent form from them (18 female and 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 with hepatic, renal or neurological diseases and using sedative- hypnotic, anticonvulsive and stimulant drugs and pregnant patients were excluded. Then they have been divided into two groups by closed envelope drawing method randomly and were allowed to stay hungry at least 8 hours. All the patients were applied the cognitive functions during the premedication visit MMSE (Mini Mental State Examination) that has quite practical usage and the test called Standardized Mini Mental Test Examination(SMMT-E) for the untrained persons. Test composed of question-answer in order to calculate the remembering, caution and calculation structure. All patients SMMTE scores were recorded. In the operation room, patients were applied the standard D-II derivation electrocardiography, heart beat rate, non-invasive arterial pressure, peripheral oxygen saturation (SpO2) and Bispectral Index (BİS) monitorization. Serum sale infusion was started by opening the vascular access with 18-20 gauge cannula. The skin of forehead and the temporal side were cleaned with alcohol cotton for the BİS monitorization. The electrode in the proximal part of the three electrodes of disposable BİS sensor was adhered to the middle of the forehead; the distal electrode to the temporal area on the eye line and the other electrode in between them both were adhered. The BİS values (BİS Monitor, Aspect, USA) were continuously monitored. The Group I (TİVA, n= 20) were received propofol-remifentanil and the Grup II (TİVA+D, n= 20) propofol- remifentanil and additional dexmedetomidine infusion.

Induction of propofol infusion in all two groups was started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS values were arranged between 40-60 until the end of the operation. At the same time remifentanil infusion 0.5 μg.kg-1 was applied as opioid and arranged according to the tension artery and heart rate. The dexmedetomidine infusion has been 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 intubation the carbon dioxide concentration was recorded in all periods.

The patients were ventilated mechanically after the intubation in order to be ETCO2 (end-tidal carbon dioxide) 30-44 mmHg, tidal volume 8-10 mL. kg-1 . In case of tachycardia or hypertension the opioid dose was reduced in case of bradycardia or hypertension while the opioid dose was being increased. Propofol infusion was arranged to be kept in between BİS score 40-50. The effect of the used muscle relaxant was returned by neostigmine 0,05- 0,07 mg. kg-1 i.v. and atropin 0,03 mg. kg -1 i.v. After the operation all patients have been 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • under going lumbar disk hernia operation
  • 20-60 years old
  • ASA (American Society of Anesthesiologists Physical Status classification) classification I-II

Exclusion criteria

  • 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)

Treatment and study plan

Remifentanil

Drug

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

Other names: ultiva

Propofol

Drug

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

Dexmedetomidine

Drug

0.5 microgram/kg infusion, no changes

Other names: precedex

Rocuronium

Drug

0.5 mg/kg iv for intubation, no changes

Other names: esmeron

Primary outcomes

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

    Time frame: Postoperative hour 2

    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

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

    Time frame: Postoperative month one

    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

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

    Time frame: postoperative week one

    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

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

    Time frame: Postoperative hour 24

    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

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 16, 2015
Registry last updated
May 17, 2024

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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