Effect of flumazenil drip on speed of recovery and complications in severe acute benzodiazepine toxicity
Design
In this phase 2-3 single-blind clinical trial, a total of 50 patients with severe benzodiazepine poisoning in need of intubation are included. They are randomly assigned into 2 groups (receiving loading dose of flumazenil followed by conservative treatment versus continuous infusion of flumazenil). The data is analyzed by SPSS 21.
Settings and conduct
Between 2018 and 2019, 50 patients referring to Loghman Hakim toxicology ED with severe benzodiazepine toxicity are assigned into the case (those who will receive a flumazenil drip after the loading dose of flumazenil) and control (those who only receive conservative management after single loading dose of flumazenil). Patients undergo intubation if needed and receive the conservative management. In the control group, a flumazenil drip of at least 200 µg/h is initiated. The dose, however, is measured then increased or decreased based upon the patients’ clinical characteristics and need. The drip dose is actually titrated to maintain the patients’ consciousness acceptable (14 or 15).
Participants/Inclusion and exclusion criteria
A total of 50 severely benzodiazepine-poisoned patients (in
need for intubation) are included. Those with abnormal vital signs on presentation, history of seizure, ingestion or use of any drug/medication that can precipitate seizure, head trauma, possible brain edema and increased intracranial pressure, and hypoxemia are excluded.
Intervention groups
Intervention group: treated by administration of flumazenil drip (initial dose of 200 microgram/hour). Control group: routine conservative care
Main outcome variables
Mortality- Complications during treatment- Need for intubation after initial response to flumazenil
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120629010133N3
Registration date:2020-05-31, 1399/03/11
Registration timing:retrospective
Last update:2020-05-31, 1399/03/11
Update count:0
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Hossein Hassanian-Moghaddam
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
hassanian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
2018-05-25, 1397/03/04
Actual recruitment end date
2019-10-22, 1398/07/30
Trial completion date
2019-10-22, 1398/07/30
Scientific title
Effect of Flumazenil Drip On Speed Of Recovery And Prevention Of Complications In Severe Acute Benzodiazepine Toxicity
Public title
Effect of Flumazenil Drip On Speed Of Recovery And Prevention Of Complications In Severe Acute Benzodiazepine Toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severely benzodiazepine-poisoned patients (in need for intubation and mechanical ventilation) with otherwise normal vital signs
Exclusion criteria:
Abnormal vital signs on presentation,
history of seizure,
history of ingestion or use of any drug/medication that can predispose the patient to seizure,
history of head trauma,
possible brain edema and increased intracranial pressure,
history of hypoxemia
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are blind to receive flumazenil drip or not
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences Ethics Committee
Street address
Yaman Street- Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-03-05, 1396/12/14
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.428
Health conditions studied
1
Description of health condition studied
Benzodiazepine poisoning
ICD-10 code
T42.0
ICD-10 code description
Poisoning by, adverse effect of and underdosing of hydantoin derivatives
Primary outcomes
1
Description
Mortality-
Timepoint
7 days after admission
Method of measurement
Observation and questionnaire recording
2
Description
Complications during hospitalization
Timepoint
7 days after admission
Method of measurement
Observation and questionnaire recording
3
Description
Intubation
Timepoint
7 days after admission
Method of measurement
Observation and questionnaire recording
Secondary outcomes
1
Description
Hospitalization period
Timepoint
At discharge or death
Method of measurement
Observation and questionnaire recording
Intervention groups
1
Description
Intervention group: Administration of flumazenil drip (initial dose of 200 micro per hour and its adjustment based on patient's situations) followed by its tapering
Category
Treatment - Drugs
2
Description
Control group: are the patients who do not receive maintenance dose of flumazenil and are only followed and treated conservatively.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital-Poisoning Ward
Full name of responsible person
Hossein Hassanian-Moghaddam
Street address
Lashgar Street- Sout Karegar Street
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5540 9534
Fax
+98 21 5540 9534
Email
hassanian@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
NIMAD (National Institute for Medical Research Development)