Trial Outcomes & Findings for Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery (NCT NCT04561375)

NCT ID: NCT04561375

Last Updated: 2023-12-13

Results Overview

The total amount of fentanyl consumed in PACU.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 61 participants
• Primary outcome timeframe: About 3 hours in PACU
• Results posted on: 2023-12-13

Participant Flow

Participant milestones

Measure	Intervention Group 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia. Sufentanil: 30 µg tablet of sublingual sufentanil	Control Group placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia Fentanyl: 50 µg fentanyl
Overall Study STARTED	35	26
Overall Study COMPLETED	35	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

Baseline characteristics by cohort

Measure	Intervention Group n=35 Participants 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia. Sufentanil: 30 µg tablet of sublingual sufentanil	Control Group n=26 Participants placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia Fentanyl: 50 µg fentanyl	Total n=61 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 7.4 • n=5 Participants	51.5 years STANDARD_DEVIATION 12.3 • n=7 Participants	53.8 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized White	35 Participants n=5 Participants	25 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized non-White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Body Mass Index (BMI)	29.9 kg/m2 STANDARD_DEVIATION 5.2 • n=5 Participants	33.8 kg/m2 STANDARD_DEVIATION 7.4 • n=7 Participants	31.6 kg/m2 STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: About 3 hours in PACU

The total amount of fentanyl consumed in PACU.

Outcome measures

Measure	Intervention Group n=35 Participants 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia. Sufentanil: 30 µg tablet of sublingual sufentanil	Control Group n=26 Participants placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia Fentanyl: 50 µg fentanyl
Total Consumption of Fentanyl 50 µg	2 Participants	5 Participants
Total Consumption of Fentanyl 0 µg	25 Participants	11 Participants
Total Consumption of Fentanyl 25 µg	4 Participants	5 Participants
Total Consumption of Fentanyl 100 µg	4 Participants	4 Participants
Total Consumption of Fentanyl 150 µg	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1.5 hours

Recovery will be considered complete at the time an order is placed for progression to phase II.

Outcome measures

Measure	Intervention Group n=35 Participants 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia. Sufentanil: 30 µg tablet of sublingual sufentanil	Control Group n=26 Participants placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia Fentanyl: 50 µg fentanyl
Phase 1 Recovery Time	77 minutes Standard Deviation 30	66 minutes Standard Deviation 18

SECONDARY outcome

Timeframe: 1 - 2 hours.

This will be determined per facility protocol-scheduled assessments using the CCF Phase II Discharge Scoring tool. The time that the minimum acceptable score of 14 is achieved will be recorded

Outcome measures

Measure	Intervention Group n=35 Participants 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia. Sufentanil: 30 µg tablet of sublingual sufentanil	Control Group n=26 Participants placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia Fentanyl: 50 µg fentanyl
Time to Fitness for PACU Discharge	120 minutes Standard Deviation 47	114 minutes Standard Deviation 31

OTHER_PRE_SPECIFIED outcome

Timeframe: About 3 hours in PACU

The total amount of fentanyl consumed in PACU.

Outcome measures

Measure	Intervention Group n=35 Participants 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia. Sufentanil: 30 µg tablet of sublingual sufentanil	Control Group n=26 Participants placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia Fentanyl: 50 µg fentanyl
Total Consumption of Fentanyl in PACU	0 µg Interval 0.0 to 25.0	25 µg Interval 0.0 to 50.0

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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. Daniel Sessler

Cleveland Clinic

Phone: 2168702620

Email: ds@ccf.org

Results disclosure agreements

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