Trial Outcomes & Findings for Cognitive Functions After TIVA With Dexmedetomidine (NCT NCT02631135)
NCT ID: NCT02631135
Last Updated: 2024-05-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Postoperative hour 2
Results posted on
2024-05-17
Participant Flow
patients, who scheduled to have general anesthesia for surgery of a prolapsed lumbar disc
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)
Participant milestones
| Measure |
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 (bispectral index) values were arranged 40-60 until the end of operation
Rocuronium: 0.5 mg/kg iv for intubation, no change
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Functions After TIVA With Dexmedetomidine
Baseline characteristics by cohort
| Measure |
Group 1 (TIVA)
n=21 Participants
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
|
Group 2 (TIVA+D)
n=20 Participants
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
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.60 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
41.65 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
43.62 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
weight
|
75.7 kg
STANDARD_DEVIATION 8.8 • n=5 Participants
|
84.1 kg
STANDARD_DEVIATION 13.1 • n=7 Participants
|
79.9 kg
STANDARD_DEVIATION 11.83 • n=5 Participants
|
|
height
|
168.65 cm
STANDARD_DEVIATION 7.84 • n=5 Participants
|
173.4 cm
STANDARD_DEVIATION 10.2 • n=7 Participants
|
171.02 cm
STANDARD_DEVIATION 9.31 • n=5 Participants
|
|
Mini Mental State examination
|
29.15 units on a scale
n=5 Participants
|
28.60 units on a scale
n=7 Participants
|
28.87 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative hour 2Population: per protocol
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
Outcome measures
| Measure |
Group 1 (TIVA)
n=21 Participants
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
|
Group 2 (TIVA+D)
n=20 Participants
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
|
|---|---|---|
|
Mini Mental State Examination (MMSE) Score at the Second Hour After Surgery
|
27.40 scores on a scale
Standard Deviation 1.31
|
26.45 scores on a scale
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: Postoperative month onePopulation: per protocol
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
Outcome measures
| Measure |
Group 1 (TIVA)
n=20 Participants
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
|
Group 2 (TIVA+D)
n=20 Participants
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
|
|---|---|---|
|
Mini Mental State Examination (MMSE) Score at the First Month After Surgery
|
29.15 scores on a scale
Standard Deviation 1.18
|
28.65 scores on a scale
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: postoperative week onePopulation: per protocol
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
Outcome measures
| Measure |
Group 1 (TIVA)
n=20 Participants
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
|
Group 2 (TIVA+D)
n=20 Participants
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
|
|---|---|---|
|
Mini Mental State Examination (MMSE) Score at the First Week After Surgery
|
28.95 scores on a scale
Standard Deviation 1.31
|
28.15 scores on a scale
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: Postoperative hour 24Population: per protocol
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
Outcome measures
| Measure |
Group 1 (TIVA)
n=21 Participants
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
|
Group 2 (TIVA+D)
n=20 Participants
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
|
|---|---|---|
|
Mini Mental State Examination (MMSE) Score at the 24th Hour After Surgery
|
29.05 scores on a scale
Standard Deviation 1.23
|
28.60 scores on a scale
Standard Deviation 1.09
|
Adverse Events
Group 1 (TIVA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (TIVA+D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place