Trial Outcomes & Findings for Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures (NCT NCT00937924)

NCT ID: NCT00937924

Last Updated: 2024-02-26

Results Overview

The percentage of participants who could not complete the procedure due inability to achieve proper sedation level

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 304 participants
• Primary outcome timeframe: From onset of sedation to completion of procedure, approximately 1 hour.
• Results posted on: 2024-02-26

Participant Flow

Participant milestones

Measure	1 Normal Saline Control. Normal Saline Injections.	2 Diphenhydramine Diphenhydramine injections given as adjunct sedative.	3 Promethzine Promethazine given as an adjunct sedative.
Overall Study STARTED	102	101	101
Overall Study COMPLETED	58	57	60
Overall Study NOT COMPLETED	44	44	41

Reasons for withdrawal

Measure	1 Normal Saline Control. Normal Saline Injections.	2 Diphenhydramine Diphenhydramine injections given as adjunct sedative.	3 Promethzine Promethazine given as an adjunct sedative.
Overall Study Lost to Follow-up	44	44	41

Baseline Characteristics

Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures

Baseline characteristics by cohort

Measure	1- Saline Control Group n=57 Participants Control. These patients will receive Normal Saline Injections to serve as controls. Saline: Saline solution injections	2 - Diphenhydramine Sedation Group n=58 Participants These patients will receive Diphenhydramine injections given as adjunct sedative. Diphenhydramine: Diphenhydramine injections	3 - Promethazine Sedation Group n=60 Participants Promethazine given as an adjunct sedative. Promethazine: Promethazine	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	90 Participants n=4 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	28 Participants n=7 Participants	30 Participants n=5 Participants	85 Participants n=4 Participants
Age, Continuous	57 years STANDARD_DEVIATION 3 • n=5 Participants	56 years STANDARD_DEVIATION 3 • n=7 Participants	58 years STANDARD_DEVIATION 3 • n=5 Participants	57 years STANDARD_DEVIATION 3 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants	78 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	32 Participants n=7 Participants	34 Participants n=5 Participants	97 Participants n=4 Participants

PRIMARY outcome

Timeframe: From onset of sedation to completion of procedure, approximately 1 hour.

The percentage of participants who could not complete the procedure due inability to achieve proper sedation level

Outcome measures

Measure	1 - Control Arm: Normal Saline Injections. n=58 Participants Control Arm: Normal Saline Injections. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of normal saline prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	2 - Diphenhydramine Injections Given as Adjunct Sedative. n=57 Participants Diphenhydramine injections given as adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of diphenhydramine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	3 - Promethazine Given as an Adjunct Sedative. n=60 Participants Promethazine given as an adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of promethizine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.
Average Percentage of Sedation Failures	14 percentage of participants Standard Deviation 2	13 percentage of participants Standard Deviation 2	5 percentage of participants Standard Deviation 1

PRIMARY outcome

Timeframe: Pre-Endoscopic Procedure (up to 1 hour maximum)

Outcome measures

Measure	1 - Control Arm: Normal Saline Injections. n=58 Participants Control Arm: Normal Saline Injections. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of normal saline prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	2 - Diphenhydramine Injections Given as Adjunct Sedative. n=57 Participants Diphenhydramine injections given as adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of diphenhydramine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	3 - Promethazine Given as an Adjunct Sedative. n=60 Participants Promethazine given as an adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of promethizine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.
Time to Achieve Adequate Level of Sedation to Begin Procedure	15 minutes Standard Deviation 3	13 minutes Standard Deviation 4	14 minutes Standard Deviation 5

PRIMARY outcome

Timeframe: Post-Endoscopic Procedure

Outcome measures

Measure	1 - Control Arm: Normal Saline Injections. n=58 Participants Control Arm: Normal Saline Injections. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of normal saline prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	2 - Diphenhydramine Injections Given as Adjunct Sedative. n=57 Participants Diphenhydramine injections given as adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of diphenhydramine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	3 - Promethazine Given as an Adjunct Sedative. n=60 Participants Promethazine given as an adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of promethizine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.
Time for Recovery	21.3 minutes Standard Deviation 5	29.5 minutes Standard Deviation 4	51.5 minutes Standard Deviation 6

SECONDARY outcome

Timeframe: Approximately 3 hours.

Outcome measures

Measure	1 - Control Arm: Normal Saline Injections. n=58 Participants Control Arm: Normal Saline Injections. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of normal saline prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	2 - Diphenhydramine Injections Given as Adjunct Sedative. n=57 Participants Diphenhydramine injections given as adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of diphenhydramine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.	3 - Promethazine Given as an Adjunct Sedative. n=60 Participants Promethazine given as an adjunct sedative. After placement of IV catheter and obtaining baseline vitals, including blood pressure, pulse, and oxygen saturation, subjects received pre-procedure injection of promethizine prior to standard sedation agents. The standard agents included standard doses of meperidine and midazolam, both administered via IV catheter and titrated under standard endoscopy protocol.
Adverse Symptoms From Sedative Agents	0 adverse events Standard Deviation 0	0 adverse events Standard Deviation 0	0 adverse events Standard Deviation 0

Adverse Events

1 - Control. Normal Saline Injections.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 - Diphenhydramine Injections Given as Adjunct Sedative.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3 - Promethazine Given as an Adjunct Sedative.

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. Kenneth Chang

University of California, Irvine

Phone: 714-456-6187

Email: kchang@uci.edu

Results disclosure agreements

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