Skip to content

Acu Tens Versus Low Level Laser After Open Heart Surgeries

Acu Tens Versus Low Level Laser on Autonomic and Heamodynamic Stability After Open Heart Surgeries.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06637085
Enrollment
60
Registered
2024-10-15
Start date
2023-01-12
Completion date
2024-02-03
Last updated
2024-10-15

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

Conditions

Heart Arrhythmia

Brief summary

Increase in heart rate (HR) is a normal sympathetic response to body trauma and a common consequence of major surgical procedures,A high resting HR is associated with increased myocardial work that may be detrimental to patients with a marginal myocardial oxygen supply,the aim of this study is To compare between the effects of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery.

Detailed description

Autonomic function reached lowest values 3-6 days after coronary artery by pass graft (CABG) and could take up to 60 days to return to pre-surgery values (pedro et al., 2005). Alterations in pulse may provide a first indication that a patient is developing hemodynamic instability. While many factors may influence the pulse rate, including fever, exercise, medications, and thyroid hormone status, a high pulse rate is often a sign of high levels of endogenous catecholamines, blood loss or dehydration (Jonathan ,2009.) Hemodynamically unstable patients don't have enough pressure in the circulatory system to keep blood flowing reliably to all the various parts of the body where it needs to be at the same time. Vagus nerve stimulation (VNS) can increase HRV and reduce sympathetic nerve outflow, which is desirable in conditions characterized by enhanced sympathetic nerve activity . Application of Acu-TENS over acu-point PC6 facilitated a faster return of resting HR to preoperative levels, maintained BP during the acute postoperative period and enhanced a quicker return of rate pressure product (RPP), in patients after acute cardiac surgery . Faster return of the raised resting HR to preoperative levels in Acu-TENS application was possibly due to induced vagal stimulation and/or inhibition of sympathetic neural activity through the acu-points PC6 . Low level laser therapy (LLLT) is a non-invasive and safe method, to recover parasympathetic/sympathetic nervous system balance . this study show the differences between the effect of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery

Interventions

DEVICELLLT

low level laser therapy Probe laser device: (Laserklasse2M, EN60825-1, +A2:2002, W.L= 635-670nm, P\<6mW, German):low level laser therapy It will be used to stimulate vagus nerve .

OTHERtraditional physical therapy

traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)

DEVICEACU TENSE

Acu-TENS device (Digital TENS, EAF20, JERF20BD0604, add manufacturing country): It will be used to stimulate vagus nerve throug h the acupoint PC6 .

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 1- 60 patients from both sexes . 2- undergo cardiac surgery through a median sternotomy. 3- age will be ranged from 45-65 years old. 4-Body mass index from 25 to 29.9 kg/m25-

Exclusion criteria

* 1- Previous thoracic surgery. 2- Emergency or urgent cardiac surgery. 3- hypoxemia with partial pressure of oxygen in arterial blood \<60 mmHg. 4- Renal insufficiency with serum creatinine ≤1.8 mg/dl after surgery. 5- Other medical conditions such as uncontrolled diabetes, and hypertension . 6- Patients who are unable to follow verbal instructions.

Design outcomes

Primary

MeasureTime frameDescription
heartrate variability.heart rate variability parameters recorded for 24 hours 1st day post operative and at the last day before discharge from hospital for each group. before discharge from hospital .SDANN Standard deviation of the averages of RR intervals in all 50minute segments of a 24-hour recording.rMSSD Square root of the mean of the squares of differences between adjacent RR intervals

Secondary

MeasureTime frameDescription
Atrial fibrillationAF recorded in 24 hours 1st day post operative and at the last day before discharge from hospital for each group.Atrial fibrillation occurs in 10% to 65% of patients after cardiac surgery, usually on the second or third postoperative day. Postoperative atrial fibrillation is associated with increased morbidity and mortality and longer, more expensive hospital stay

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026