Bariatric Surgery, Bariatric Surgery Candidate
Conditions
Keywords
Bariatric, Diaphragmatic dysfunction
Brief summary
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
Detailed description
Bariatric surgery is associated with several postoperative consequences, including challenging pain control, respiratory complications, and diaphragmatic dysfunction. Postoperative diaphragmatic dysfunction is defined as a diaphragmatic excursion of less than 10 mm. There is substantial evidence that diaphragmatic ultrasound provides a reliable and accurate assessment of diaphragmatic function in both intensive care unit and perioperative settings. The present randomized controlled trial aims to evaluate the influence of transcutaneous electrical nerve stimulation on postoperative diaphragmatic dysfunction in morbidly obese patients undergoing bariatric surgery.
Interventions
DEVICETranscutaneous nerve stimulator
The EM49 will be set to a TENS program with a frequency of 80-100 Hz and a pulse width of 200 μs
DEVICESham TENS
Electrodes will be placed identically, but no current will be delivered (sham TENS)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Application of transcutaneous electric nerve stimulator
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index \> 40 kg/m2 * ASA II
Exclusion criteria
* Limited diaphragmatic ultrasound views * Patient with pulmonary diseases (COPD, bronchial asthma, and interstitial fibrosis) * Patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative diaphragmatic dysfunction | 2 hours after surgery | Diaphragmatic excursion \< 10 mm 2 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced vital capacity (liters) | Before and at 2 and 24 hours postoperatively | is the maximum volume of air that can forcibly exhaled after taking maximum breath |
| Numeric rating scale | Within 24 hours after surgery | To quantify pain from 0 to 10 (with 10 indicates worst pain) |
| Nalbuphine consumption | 24 hours after surgery | Total postoperative nalbuphine consumption |
| Forced expiratory volume in one second (Liter) | Before and at 2 and 24 hours | Maximum volume of air can be exhaled in the first second after maximum inspiration |
| Peak expiratory flow rate (Liter/ second) | Baseline, 2, and 24 hours after surgery | Maximum flow rate during forced expiration after maximum inhalation |
Countries
Egypt
Contacts
CONTACTMina Adolf Helmy, MD
Outcome results
None listed