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The effects of atropine and aminophylline premedication on respiratory problems after electroconvulsive therapy.

The effects of atropine and aminophylline premedication on respiratory problems after electroconvulsive therapy: a prospective, randomized, crossover trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000274673
Enrollment
52
Registered
2014-03-14
Start date
2011-06-01
Completion date
2013-03-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Electroconvulsive therapy (ECT) is a safe and efficient treatment as a last line of intervention for psychiatric disorders. Mild and short-time respiratory problems can observed after ECT. In the present study, we investigated the effects of atropine and aminophylline on respiratory problems that occur after ECT under general anesthesia The present study is a randomized, double-blind, crossover trial. All patients had 5 ECT sessions. During the first three of which the patients entered the study either non-premedicated as part of the Control Group, premedicated with atropine(0.01mg/kg) in the Atropine Group, or premedicated with aminophylline(120mg) in the Aminophylline Group. During the anesthesia induction, propofol and succinylcholine was administered. Patients were ventilated with bag and mask supported with 100% oxygen during the procedure and was continued until complete awakening of the patients. After adequate anesthesia and muscle relaxation, electroconvulsive therapy was performed. After ECT, all patients were monitored in the recovery room. Patients were discharged from the recovery room when their vital signs were stable and Modified Aldrete Scores (MAS) were over nine. Seizure time was defined as the total time between the implementation of electricity until the last seizure seen at the end of the clonic phase. The demographics, psychiatric diagnoses and hemodynamic data of the patients were recorded. The respiratory sounds were auscultated before and after ECT. Findings were recorded as normal respiratory sounds, fine crackles, coarse crackles or wheezing. Patients whose SpO2 values were <90% were recorded separately. The period of time required for recovery of pathological respiratory sounds, seizure duration and anesthesia recovery time were recorded.

Interventions

Arm 1:before anesthesia induction 0.01mg/kg atropine intravenously will be given to patients at atropine group. once only before anesthesia induction. Arm 2: before anesthesia induction 120 mg aminophylline intravenously will be given to patients at aminophylline group.once only before anesthesia induction. All patients have more than 3 ECT sessions. Patients entered the study either non-premedicated as part of the control group, premedicated with atropine in the atropine group, or premedicated

Arm 1:before anesthesia induction 0.01mg/kg atropine intravenously will be given to patients at atropine group. once only before anesthesia induction. Arm 2: before anesthesia induction 120 mg aminophylline intravenously will be given to patients at aminophylline group.once only before anesthesia induction. All patients have more than 3 ECT sessions. Patients entered the study either non-premedicated as part of the control group, premedicated with atropine in the atropine group, or premedicated with aminophylline in the aminophylline group at the first three ECT sessions.Other ECT sessions (ECT sessions that after first three) were not included in the study. The group order for the patients’ ECT procedures had been determined randomly previously, using the closed envelope method. Thus, each patient was included in every group of first 3 ECT procedures in different orders randomly. ECT sessions once every 2 or 3 days.Duration of each ECT sessions is 15-30 minutes.Duration of wash out period 2 days. Patients were monitored for heart rate (HR) by three channel electrocardiography, noninvasive blood pressure, peripheral oxygen saturation (SpO2) and three channel electroencephalogram (EEG). Ten minutes before the anesthesia induction; 5 cc of isotonic saline, 0.01 mg/kg of atropine (5 cc), and aminophylline of 120 mg (5 cc) were infused intravenously to the control, atropine, and aminophylline groups, respectively. This was followed by anesthesia induction. During the anesthesia induction, propofol was administered in 30 seconds by titration (being no less than 1 mg/kg) until the eyelash reflex was lost. When patients became unconscious, the muscle relaxant, succinylcholine (0.5 mg/kg), was administered. Patients were ventilated with bag and mask supported with 100% oxygen during the procedure and was continued until complete awakening of the patients. After adequate anesthesia and muscle relaxation, electroconvulsive therapy was performed using The Thymatron System IV device (Somatics, Inc, Lake Bluff, Ill) with bilateral fronto-temporal manner electrode placement. After Electroconvulsive therapy, we investigate the effects of atropine and aminophylline on respiratory problems incidance.

Sponsors

achmet ali
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
19 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Patients aged 19- to 65 years old with an American Society of Anesthesiologists score (ASA) of I-II who had received ECT for the first time.

Exclusion criteria

1- History of ECT during the preceding 6-month period, use of nonbenzodiazepine anticonvulsants (sodium valproate, carbamazepine, lamotrigine, or topiramate), lidocaine, theophylline, or lithium during the last week. 2- Neurologic illness or severe medical illness. 3- Pregnancy 4- Morbid obesity (BMI>40). 5- Hypertension (systolic blood pressure over 160 mmHg) and /or tachycardic (>90 beats/min) patients. 6- History of stroke, brain surgery. 7- Neuromuscular disease 8-Diagnosis of pulmonary disease (COPD, asthma, bronchiectasis, etc.). 9- Patients with abnormal respiratory auscultation signs before ECT procedure.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026