Trial Outcomes & Findings for Awake Caudal Catheter vs General Anesthesia (NCT NCT05919732)

NCT ID: NCT05919732

Last Updated: 2024-04-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Within 24 hours post operative
• Results posted on: 2024-04-02

Participant Flow

Participant milestones

Measure	Caudal Infusion Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
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	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)	Total n=20 Participants Total of all reporting groups
Age, Customized Gestational age	28.4 weeks STANDARD_DEVIATION 3.3 • n=11 Participants	30.0 weeks STANDARD_DEVIATION 4.6 • n=9 Participants	29.1 weeks STANDARD_DEVIATION 3.9 • n=20 Participants
Sex: Female, Male Female	1 Participants n=11 Participants	3 Participants n=9 Participants	4 Participants n=20 Participants
Sex: Female, Male Male	10 Participants n=11 Participants	6 Participants n=9 Participants	16 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	11 participants n=11 Participants	9 participants n=9 Participants	20 participants n=20 Participants
Weight	3.6 kg STANDARD_DEVIATION 1.0 • n=11 Participants	3.1 kg STANDARD_DEVIATION 0.9 • n=9 Participants	3.4 kg STANDARD_DEVIATION 1.0 • n=20 Participants

PRIMARY outcome

Timeframe: Within 24 hours post operative

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Number of Participants With Return to Baseline Respiratory Function.	11 Participants	9 Participants

PRIMARY outcome

Timeframe: Within 24 hours

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Surgical Completion.	11 Participants	9 Participants

PRIMARY outcome

Timeframe: 24 hours post operative

Cessation of breathing by a premature infant that lasts for more than 20 seconds and/or is accompanied by hypoxia or bradycardia.

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Number of Apneic Episodes.	0.1 Episodes Standard Deviation 0.3	0.9 Episodes Standard Deviation 1.2

PRIMARY outcome

Timeframe: 24 hours post operative

heart rate <90.

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Number of Bradycardia Events.	0 episodes Standard Deviation 0	1.0 episodes Standard Deviation 2.0

SECONDARY outcome

Timeframe: up to 10 days

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Days to Hospital Discharge From Surgery	2 Days Standard Deviation 2	1.6 Days Standard Deviation 0.7

SECONDARY outcome

Timeframe: 24 hours post operative

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Number of Episodes Requiring Post-operative Narcotics Usage.	0.3 episodes Standard Deviation 0.7	0 episodes Standard Deviation 0

SECONDARY outcome

Timeframe: Intraoperative, up to 100 minutes.

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Operative Time.	57 Minutes Standard Deviation 28	53 Minutes Standard Deviation 33

SECONDARY outcome

Timeframe: After 24 hours post operative

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Participants Requiring Mechanical Ventilation.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 24 hours post operative

Outcome measures

Measure	Caudal Infusion n=11 Participants Awake continuous caudal infusion. Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg	General Anesthesia n=9 Participants General anesthesia and single-dose caudal injection Propofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)
Number of Participants Returning to Full Feeds.	11 participants	8 participants

Adverse Events

Caudal Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Anesthesia

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

Dr. Gohalem Felema

Nemours

Phone: 904-416-5430

Email: gohalem.felema@nemours.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place