Trial Outcomes & Findings for Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery (NCT NCT03202134)
NCT ID: NCT03202134
Last Updated: 2021-02-23
Results Overview
number of minor and major complications (CLAVIEN) (DINDOO)
Recruitment status
COMPLETED
Target enrollment
204 participants
Primary outcome timeframe
One month postoperative
Results posted on
2021-02-23
Participant Flow
Participant milestones
| Measure |
Opioid Free Anesthesia (OFA)
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
149
|
|
Overall Study
COMPLETED
|
55
|
149
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Opioid Free Anesthesia (OFA)
n=55 Participants
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 Participants
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 2.8 • n=55 Participants
|
50.3 years
STANDARD_DEVIATION 1.7 • n=149 Participants
|
51.6 years
STANDARD_DEVIATION 1.4 • n=204 Participants
|
|
Sex/Gender, Customized
Sex:Female
|
55 Participants
n=55 Participants
|
149 Participants
n=149 Participants
|
204 Participants
n=204 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
history of nausea after anesthesia
|
6 Participants
n=55 Participants
|
19 Participants
n=149 Participants
|
25 Participants
n=204 Participants
|
PRIMARY outcome
Timeframe: One month postoperativenumber of minor and major complications (CLAVIEN) (DINDOO)
Outcome measures
| Measure |
Opioid Free Anesthesia (OFA)
n=55 Participants
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 Participants
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Number of Patients With One or More Complications
|
10 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 24 hours postoperativenumber of patients having Post operative nausea or vomiting (PONV)
Outcome measures
| Measure |
Opioid Free Anesthesia (OFA)
n=55 Participants
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 Participants
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Number of Patients With Post Operative Nausea or Vomiting
|
7 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 24 hours postoperativepostoperative Pain measured by visual analog scale: 0: no pain. 10 max pain
Outcome measures
| Measure |
Opioid Free Anesthesia (OFA)
n=55 Participants
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 Participants
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Postoperative Pain: Visual Analog Scale
|
1.87 score on a scale
Standard Deviation 0.65
|
4.94 score on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 24 hours postoperativemorphine consumed in mg
Outcome measures
| Measure |
Opioid Free Anesthesia (OFA)
n=55 Participants
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 Participants
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Morphine Used
|
1.95 milligram
Standard Deviation 0.84
|
4.94 milligram
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 24 hours post operativetemperature difference between free flap skin and central patient skin
Outcome measures
| Measure |
Opioid Free Anesthesia (OFA)
n=55 Participants
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 Participants
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Skin Temperature
|
1.04 degrees Celsius
Standard Deviation 0.25
|
1.41 degrees Celsius
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: up to two weekslength of hospital stay in days
Outcome measures
| Measure |
Opioid Free Anesthesia (OFA)
n=55 Participants
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 Participants
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Length of Hospital Stay
|
6.82 days
Standard Deviation 0.26
|
7.52 days
Standard Deviation 0.28
|
Adverse Events
Opioid Free Anesthesia (OFA)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Opioid Anesthesia (OA)
Serious events: 9 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Opioid Free Anesthesia (OFA)
n=55 participants at risk
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 participants at risk
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Surgical and medical procedures
Revision surgery
|
1.8%
1/55 • Number of events 1 • 1 month
using the definition of clinical trials for death and serious adverse events.
|
6.0%
9/149 • Number of events 9 • 1 month
using the definition of clinical trials for death and serious adverse events.
|
Other adverse events
| Measure |
Opioid Free Anesthesia (OFA)
n=55 participants at risk
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
|
Opioid Anesthesia (OA)
n=149 participants at risk
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
|
|---|---|---|
|
Surgical and medical procedures
Post operative nausea and vomiting
|
16.4%
9/55 • Number of events 9 • 1 month
using the definition of clinical trials for death and serious adverse events.
|
45.0%
67/149 • Number of events 67 • 1 month
using the definition of clinical trials for death and serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place