Trial Outcomes & Findings for Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery (NCT NCT06096181)
NCT ID: NCT06096181
Last Updated: 2025-11-10
Results Overview
Measure the median total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Post Op Day# 0 and 1
Results posted on
2025-11-10
Participant Flow
Study participants were recruited via investigator's review of medical records of their patients, approached by study team during inpatient or outpatient clinic visit, or referred to research team by their treating physician. Patients were enrolled from 12/20/2023 to 12/24/2024.
Participant milestones
| Measure |
Propofol + Remifentanil
Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Propofol + Dexmedetomidine
Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery
Baseline characteristics by cohort
| Measure |
Propofol + Remifentanil
n=7 Participants
Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Propofol + Dexmedetomidine
n=6 Participants
Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 Years
n=5 Participants
|
17.2 Years
n=20 Participants
|
16.5 Years
n=40 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race/Ethicity · White
|
6 Participants
n=5 Participants
|
6 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race/Ethicity · Hispanic/Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Post Op Day# 0 and 1Measure the median total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.
Outcome measures
| Measure |
Propofol + Remifentanil
n=7 Participants
Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Propofol + Dexmedetomidine
n=6 Participants
Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
|---|---|---|
|
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
MME POD 0
|
36.30 MME
Inter-Quartile Range 71.90 • Interval 34.2 to 96.8
|
70.5 MME
Inter-Quartile Range 66.98 • Interval 41.35 to 131.9
|
|
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
MME POD 1
|
57.5 MME
Interval 32.5 to 61.7
|
48 MME
Interval 41.9 to 54.1
|
PRIMARY outcome
Timeframe: Post Op Day# 0 and 1Measure the mean total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.
Outcome measures
| Measure |
Propofol + Remifentanil
n=7 Participants
Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Propofol + Dexmedetomidine
n=6 Participants
Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
|---|---|---|
|
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
MME POD 0
|
75.12 MME
Standard Deviation 71.58
|
88.93 MME
Standard Deviation 66.98
|
|
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
MME POD 1
|
54.38 MME
Standard Deviation 28.12
|
52.20 MME
Standard Deviation 27.40
|
SECONDARY outcome
Timeframe: Post Op Day# 0 and 1Measure the mean pain score of the participant on a visual analog pain scale. The VAS has two end points representing 0 ("no pain") and 10 ("worst pain ever"). It is reported at our institution as a number between 0 and 10.
Outcome measures
| Measure |
Propofol + Remifentanil
n=7 Participants
Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Propofol + Dexmedetomidine
n=6 Participants
Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
|---|---|---|
|
Mean VAS Pain Score on POD# 0 and 1
VAS POD 0
|
3.39 Visual Analog Pain Scale Score
Standard Deviation 2.30
|
2.23 Visual Analog Pain Scale Score
Standard Deviation 1.40
|
|
Mean VAS Pain Score on POD# 0 and 1
VAS POD 1
|
3.32 Visual Analog Pain Scale Score
Standard Deviation 2.81
|
3.21 Visual Analog Pain Scale Score
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Intraoperative (day of surgery)Measure the median time (mins) from completion of surgical skin closure to the participant being able to move their feet to command.
Outcome measures
| Measure |
Propofol + Remifentanil
n=7 Participants
Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Propofol + Dexmedetomidine
n=6 Participants
Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
|---|---|---|
|
Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins)
|
14 Minutes
Interval 9.0 to 18.0
|
21.5 Minutes
Interval 10.0 to 30.75
|
SECONDARY outcome
Timeframe: Intraoperative (day of surgery)Measure the median time (mins) from completion of surgical skin closure to extubation.
Outcome measures
| Measure |
Propofol + Remifentanil
n=7 Participants
Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
Propofol + Dexmedetomidine
n=6 Participants
Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.
|
|---|---|---|
|
Time From Skin Closure to Extubation
|
15 Minutes
Interval 9.5 to 19.0
|
22 Minutes
Interval 11.75 to 31.75
|
Adverse Events
Propofol + Remifentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol + Dexmedetomidine
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