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Cognitive Functions After TIVA With Dexmedetomidine

Cognitive Functions After TIVA With Dexmedetomidine

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02631135
Enrollment
40
Registered
2015-12-16
Start date
2008-01-31
Completion date
2008-10-31
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Confusion

Keywords

Dexmedetomidine, cognitive functions, MMSE

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.

Detailed description

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.

Interventions

DRUGRemifentanil

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

DRUGPropofol

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

DRUGDexmedetomidine

0.5 microgram/kg infusion, no changes

DRUGRocuronium

0.5 mg/kg iv for intubation, no changes

Sponsors

Uludag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Mini Mental State Examination (MMSE) Score at the Second Hour After SurgeryPostoperative hour 2The 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
Mini Mental State Examination (MMSE) Score at the First Month After SurgeryPostoperative month oneThe 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
Mini Mental State Examination (MMSE) Score at the First Week After Surgerypostoperative week oneThe 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
Mini Mental State Examination (MMSE) Score at the 24th Hour After SurgeryPostoperative hour 24The 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

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

patients, who scheduled to have general anesthesia for surgery of a prolapsed lumbar disc

Pre-assignment details

pregnant patients and those with hepatic, renal or neurological disease and those using sedative, hypnotic, anticonvulsive or stimulant drugs were excluded from the trail before assignment to groups and one patient excluded from the study (can not be able to reach after surgery)

Participants by arm

ArmCount
Group 1 (TIVA)
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) Remifentanil: In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased Propofol: BIS values were arranged 40-60 until the end of operation Rocuronium: 0.5 mg/kg iv for intubation, no change
21
Group 2 (TIVA+D)
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) Remifentanil: In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased Propofol: BIS values were arranged 40-60 until the end of operation Dexmedetomidine: 0.5 microgram/kg infusion, no changes Rocuronium: 0.5 mg/kg iv for intubation, no change
20
Total41

Baseline characteristics

CharacteristicGroup 2 (TIVA+D)TotalGroup 1 (TIVA)
Age, Continuous41.65 years
STANDARD_DEVIATION 10.1
43.62 years
STANDARD_DEVIATION 10.8
45.60 years
STANDARD_DEVIATION 11.5
height173.4 cm
STANDARD_DEVIATION 10.2
171.02 cm
STANDARD_DEVIATION 9.31
168.65 cm
STANDARD_DEVIATION 7.84
Mini Mental State examination28.60 units on a scale28.87 units on a scale29.15 units on a scale
Region of Enrollment
Turkey
20 participants41 participants21 participants
Sex: Female, Male
Female
8 Participants18 Participants10 Participants
Sex: Female, Male
Male
12 Participants23 Participants11 Participants
weight84.1 kg
STANDARD_DEVIATION 13.1
79.9 kg
STANDARD_DEVIATION 11.83
75.7 kg
STANDARD_DEVIATION 8.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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

Time frame: Postoperative hour 24

Population: per protocol

ArmMeasureValue (MEAN)Dispersion
Group 1 (TIVA)Mini Mental State Examination (MMSE) Score at the 24th Hour After Surgery29.05 scores on a scaleStandard Deviation 1.23
Group 2 (TIVA+D)Mini Mental State Examination (MMSE) Score at the 24th Hour After Surgery28.60 scores on a scaleStandard Deviation 1.09
Primary

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

Time frame: Postoperative month one

Population: per protocol

ArmMeasureValue (MEAN)Dispersion
Group 1 (TIVA)Mini Mental State Examination (MMSE) Score at the First Month After Surgery29.15 scores on a scaleStandard Deviation 1.18
Group 2 (TIVA+D)Mini Mental State Examination (MMSE) Score at the First Month After Surgery28.65 scores on a scaleStandard Deviation 1.08
Primary

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

Time frame: postoperative week one

Population: per protocol

ArmMeasureValue (MEAN)Dispersion
Group 1 (TIVA)Mini Mental State Examination (MMSE) Score at the First Week After Surgery28.95 scores on a scaleStandard Deviation 1.31
Group 2 (TIVA+D)Mini Mental State Examination (MMSE) Score at the First Week After Surgery28.15 scores on a scaleStandard Deviation 1.26
Primary

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

Time frame: Postoperative hour 2

Population: per protocol

ArmMeasureValue (MEAN)Dispersion
Group 1 (TIVA)Mini Mental State Examination (MMSE) Score at the Second Hour After Surgery27.40 scores on a scaleStandard Deviation 1.31
Group 2 (TIVA+D)Mini Mental State Examination (MMSE) Score at the Second Hour After Surgery26.45 scores on a scaleStandard Deviation 1.19

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026