Trial Outcomes & Findings for A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia (NCT NCT02190903)
NCT ID: NCT02190903
Last Updated: 2018-07-30
Results Overview
Delirium will be assessed by the Confusion Assessment Method Instrument (CAM), a validated method of assessing delirium based on the presence of both (1) an acute onset of signs and symptoms with a fluctuating course AND (2) inattention; PLUS (3) disorganized thinking OR (4) an altered level of consciousness.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Up to 5 days post hip fracture surgery
Results posted on
2018-07-30
Participant Flow
A total of 15 patients provided informed consent for participation; 3 were withdrawn from the study prior to randomization. 2 of these patients were withdrawn due to ineligibility; 1 was withdrawn due to other reasons.
Participant milestones
| Measure |
General Endotracheal Anesthesia
Standard care general endotracheal anesthesia
General endotracheal anesthesia: General Anesthesia
Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol.
|
Regional (Spinal) Anesthesia
Standard care spinal anesthesia
Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia
Baseline characteristics by cohort
| Measure |
General Endotracheal Anesthesia
n=6 Participants
Standard care general endotracheal anesthesia
General endotracheal anesthesia: General Anesthesia
Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol.
|
Regional (Spinal) Anesthesia
n=6 Participants
Standard care spinal anesthesia
Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
n=5 Participants
|
80.5 years
n=7 Participants
|
71.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days post hip fracture surgeryDelirium will be assessed by the Confusion Assessment Method Instrument (CAM), a validated method of assessing delirium based on the presence of both (1) an acute onset of signs and symptoms with a fluctuating course AND (2) inattention; PLUS (3) disorganized thinking OR (4) an altered level of consciousness.
Outcome measures
| Measure |
General Endotracheal Anesthesia
n=6 Participants
Standard care general endotracheal anesthesia
General endotracheal anesthesia: General Anesthesia
Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol.
|
Regional (Spinal) Anesthesia
n=6 Participants
Standard care spinal anesthesia
Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen.
|
|---|---|---|
|
Number of Participants With Postoperative Delirium After Hip Fracture Surgery
|
2 Participants
|
0 Participants
|
Adverse Events
General Endotracheal Anesthesia
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Regional (Spinal) Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
General Endotracheal Anesthesia
n=6 participants at risk
Standard care general endotracheal anesthesia
General endotracheal anesthesia: General Anesthesia
Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol.
|
Regional (Spinal) Anesthesia
n=6 participants at risk
Standard care spinal anesthesia
Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Other adverse events
Adverse event data not reported
Additional Information
Mark D Neuman
University of Pennsylvania School of Medicine
Phone: 2157467468
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place