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Cognitive Functions After TIVA With Dexmedetomidine

Primary Purpose

Postoperative Confusion

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Remifentanil
Propofol
Dexmedetomidine
Rocuronium
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Confusion focused on measuring Dexmedetomidine, cognitive functions, MMSE

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Uludag University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group 1 (TIVA)

Group 2 (TIVA+D)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

all patients cognitive functions examination by MMSE (Mini Mental State Examination) test
The cognitive function evaluation performed by MMSE test at the second hour of the surgery
all patients cognitive functions examination by MMSE (Mini Mental state examination)
The MMSE test evaluation performed by MMSE test at 24th hour, 1 week, 1 year after the surgery

Secondary Outcome Measures

Full Information

First Posted
November 30, 2015
Last Updated
December 11, 2015
Sponsor
Uludag University
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1. Study Identification

Unique Protocol Identification Number
NCT02631135
Brief Title
Cognitive Functions After TIVA With Dexmedetomidine
Official Title
Cognitive Functions After TIVA With Dexmedetomidine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 15 male 25 female totally 40 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 (15 male and 25 female) totally 40 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Confusion
Keywords
Dexmedetomidine, cognitive functions, MMSE

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (TIVA)
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
Group 2 (TIVA+D)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
ultiva
Intervention Description
In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
BIS values were arranged 40-60 until the end of operation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
0.5 microgram/kg infusion, no changes
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
esmeron
Intervention Description
0.5 mg/kg iv for intubation, no change
Primary Outcome Measure Information:
Title
all patients cognitive functions examination by MMSE (Mini Mental State Examination) test
Description
The cognitive function evaluation performed by MMSE test at the second hour of the surgery
Time Frame
2nd hour
Title
all patients cognitive functions examination by MMSE (Mini Mental state examination)
Description
The MMSE test evaluation performed by MMSE test at 24th hour, 1 week, 1 year after the surgery
Time Frame
change from baseline in cognitive functions at one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hulya Bilgin, professor
Organizational Affiliation
Uludag University
Official's Role
Study Director
Facility Information:
Facility Name
Uludag University
City
Bursa
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
9447431
Citation
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.
Results Reference
background
PubMed Identifier
16037733
Citation
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.
Results Reference
background
PubMed Identifier
16803911
Citation
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.
Results Reference
background
PubMed Identifier
11698314
Citation
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.
Results Reference
result
PubMed Identifier
15721724
Citation
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.
Results Reference
result

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Cognitive Functions After TIVA With Dexmedetomidine

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