Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorCairo University
About this trial
Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body mass index > 40 kg/m2
ASA II
Disqualifiers
Limited diaphragmatic ultrasound views
Patient with pulmonary diseases (COPD, bronchial asthma, and interstitial fibrosis)
Patient refusal
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous nerve stimulator
DeviceThe EM49 will be set to a TENS program with a frequency of 80-100 Hz and a pulse width of 200 μs
Sham TENS
DeviceElectrodes will be placed identically, but no current will be delivered (sham TENS)
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: TENSActive comparator 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of postoperative diaphragmatic dysfunction
Diaphragmatic excursion \< 10 mm 2 hours after surgery
Time frame
2 hours after surgerySecondary outcomes
1
Forced vital capacity (liters)
is the maximum volume of air that can forcibly exhaled after taking maximum breath
Time frame
Before and at 2 and 24 hours postoperatively2
Numeric rating scale
To quantify pain from 0 to 10 (with 10 indicates worst pain)
Time frame
Within 24 hours after surgery3
Nalbuphine consumption
Total postoperative nalbuphine consumption
Time frame
24 hours after surgery4
Forced expiratory volume in one second (Liter)
Maximum volume of air can be exhaled in the first second after maximum inspiration
Time frame
Before and at 2 and 24 hoursSponsors and contacts
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Source ClinicalTrials.gov