Trial Outcomes & Findings for The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm (NCT NCT01445847)

Last Updated: 2017-05-22

Results Overview

There were 4 scores of laryngospasm: 0 = No Laryngospasm 1. = Stridor or partial laryngospasm 2. = Complete Laryngospasm 3. = Cyanosis

Recruitment status

TERMINATED

Study phase

Target enrollment

134 participants

Primary outcome timeframe

within first 15 minutes post-dose

Results posted on

2017-05-22

Participant Flow

Study conducted at King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia at Jan 20, 2012. Recruitment was done at Their wards within 24 hours prior to the operation

Patients were able to refuse to participate before anesthesia induction start. Therefore, patients may excluded from the study due to that reason and we decided to start assignment to groups randomly when anesthesia is induced to the patient.

Participant milestones

Participant milestones
Measure	Lidocaine Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued	Placebo Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
Overall Study STARTED	50	50
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	14	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued	Placebo Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
Overall Study Protocol Violation	13	14
Overall Study Missed Data	1	0

Baseline Characteristics

The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=36 Participants Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued	Placebo n=36 Participants Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued	Total n=72 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
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.61 years STANDARD_DEVIATION 8.73 • n=5 Participants	39.39 years STANDARD_DEVIATION 10.84 • n=7 Participants	38.01 years STANDARD_DEVIATION 10.51868595 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Saudi Arabia	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: within first 15 minutes post-dose

Population: Trial was terminated by data monitoring committee due to safety concerns

There were 4 scores of laryngospasm: 0 = No Laryngospasm 1. = Stridor or partial laryngospasm 2. = Complete Laryngospasm 3. = Cyanosis

Outcome measures

Outcome measures
Measure	Lidocaine n=36 Participants Lidocaine group received 1 mg per kg (1mL per 10kg) bolus once inhalational gas (Desflurane) is discontinued	Placebo n=36 Participants Placebo group received 1 ml per 10 kg (0.2 mL per 2 kg) bolus once inhalational gas (Desflurane) is discontinued
Number of Patients With Laryngospasm Postoperatively	0 participants	7 participants

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lidocaine n=36 participants at risk Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued	Placebo n=36 participants at risk Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/36 • within 4 months	19.4% 7/36 • Number of events 7 • within 4 months

Additional Information

Dr. Khalid Al-Faleh, Chairman, Institutional Review Board

King Saud University Medical City - College of Medicine

Phone: 966556031222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place