Trial Outcomes & Findings for Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery (NCT NCT02574832)

Last Updated: 2018-02-20

Results Overview

Elapsed time in minutes to achieve T 10 level of anesthesia. Assessed by the anesthesia care provider using crushed ice. T 10 level is numbness up to the level of the belly button.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

20 minutes after drug administration

Results posted on

2018-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Spinal Lidocaine Administration Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl. The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg. Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spinal Lidocaine Administration n=2 Participants Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl. The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg. Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 count of participants n=5 Participants
Height	163.5 centimeters n=5 Participants
Weight	54.1 Kilograms n=5 Participants
Number of live births	1 Number of live births n=5 Participants
Indication for cerclage Cervical Incompetence	1 Participants n=5 Participants
Indication for cerclage History of previous loss	1 Participants n=5 Participants
Baseline heart rate	73 Beats per minute n=5 Participants
Baseline systolic blood pressure	111.5 millimeters of mercury n=5 Participants
Baseline diastolic blood pressure	60 millimeters of mercury n=5 Participants
Estimated Gestational Age	13.3 weeks n=5 Participants
Number of times pregnant	4 Number of pregnancies n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes after drug administration

Elapsed time in minutes to achieve T 10 level of anesthesia. Assessed by the anesthesia care provider using crushed ice. T 10 level is numbness up to the level of the belly button.

Outcome measures

Outcome measures
Measure	Spinal Lidocaine Administration n=2 Participants Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl. The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg. Lidocaine Administration: The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia.
Time to T 10 Level	12.5 Minutes Interval 9.0 to 16.0

Adverse Events

Spinal Lidocaine Administration

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

Paloma Toledo, M.D.

Northwerstern University

Phone: 312-472-3585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place