Trial Outcomes & Findings for Sedation Methods During Cataract Surgery (NCT NCT03054103)

NCT ID: NCT03054103

Last Updated: 2018-09-10

Results Overview

Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 105 participants
• Primary outcome timeframe: Intraoperative, end of operation reported
• Results posted on: 2018-09-10

Participant Flow

Participant milestones

Measure	Midazolam Alone Drug: Titrated midazolam + normal saline placebo Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 5 mg Drug: Ketamine 10 MG/ML: 0.5 ML Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 10 mg Drug: Ketamine 10 MG/ML: 1 ML Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Overall Study STARTED	41	29	35
Overall Study COMPLETED	41	29	35
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sedation Methods During Cataract Surgery

Baseline characteristics by cohort

Measure	Midazolam Alone n=41 Participants Drug: Titrated midazolam + normal saline placebo Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 5 mg n=29 Participants Drug: Ketamine 10 MG/ML: 0.5 ML Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 10 mg n=35 Participants Drug: Ketamine 10 MG/ML: 1 ML Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.	Total n=105 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	10 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	25 Participants n=4 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants	21 Participants n=7 Participants	28 Participants n=5 Participants	80 Participants n=4 Participants
Age, Continuous	70.4 years STANDARD_DEVIATION 8.8 • n=5 Participants	69.1 years STANDARD_DEVIATION 8.1 • n=7 Participants	65.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	68 years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	52 Participants n=4 Participants
Region of Enrollment United States	41 Participants n=5 Participants	29 Participants n=7 Participants	35 Participants n=5 Participants	105 Participants n=4 Participants

PRIMARY outcome

Timeframe: Intraoperative, end of operation reported

Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).

Outcome measures

Measure	Midazolam Alone n=41 Participants Drug: Titrated midazolam + normal saline placebo Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 5 mg n=29 Participants Drug: Ketamine 10 MG/ML: 0.5 ML Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 10 mg n=35 Participants Drug: Ketamine 10 MG/ML: 1 ML Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Eye Mobility During Surgery (See Link to Study Protocol for Scale)	1.39 units on a scale Standard Deviation 0.63	1.41 units on a scale Standard Deviation 0.63	1.31 units on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: Obtained on the first day after surgery during the subject's routine postoperative check in the Ophthalmology Clinic.

Measure of comfort (0-3; 0=very comfortable to 3=extremely uncomfortable

Outcome measures

Measure	Midazolam Alone n=41 Participants Drug: Titrated midazolam + normal saline placebo Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 5 mg n=29 Participants Drug: Ketamine 10 MG/ML: 0.5 ML Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 10 mg n=35 Participants Drug: Ketamine 10 MG/ML: 1 ML Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Measure of Comfort (See Link to Study Protocol for Scale)	1.29 units on a scale Standard Deviation 0.62	1.18 units on a scale Standard Deviation 0.60	1.17 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: This will occur one time only, in a range of 20 to 30 minutes after the surgery is completed.

This is obtained from the records as time spent in the PACU (Recovery Room) after surgery.

Outcome measures

Measure	Midazolam Alone n=41 Participants Drug: Titrated midazolam + normal saline placebo Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 5 mg n=29 Participants Drug: Ketamine 10 MG/ML: 0.5 ML Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 10 mg n=35 Participants Drug: Ketamine 10 MG/ML: 1 ML Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
PACU Length of Stay	19.2 Minutes Standard Deviation 7.7	19.0 Minutes Standard Deviation 6.5	20.1 Minutes Standard Deviation 10.7

SECONDARY outcome

Timeframe: This will occur from time of entry into PACU to time of departure after their surgery. (One time only, in a range of 20 to 30 minutes after surgery.

Self-reported incidence of nausea. This will be assessed by asking the subjects once (just prior to discharge from the PACU) whether they experienced any nausea while they were in the PACU (Recovery Room) and will be a measurement of the count of participants that experienced nausea during this period

Outcome measures

Measure	Midazolam Alone n=41 Participants Drug: Titrated midazolam + normal saline placebo Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 5 mg n=29 Participants Drug: Ketamine 10 MG/ML: 0.5 ML Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.	Midazolam + Ketamine 10 mg n=35 Participants Drug: Ketamine 10 MG/ML: 1 ML Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Nausea	0 Participants	0 Participants	0 Participants

Adverse Events

Midazolam Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam + Ketamine 5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam + Ketamine 10 mg

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. Timothy Harwood

Wake Forest University Health Sciences

Phone: 3367164498

Email: tharwood@wakehealth.edu

Results disclosure agreements

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