Effects of electrical stimulation for reduction of pain, walking ability and respiratory function in kidney donors

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-8xtkjp
• Date of registration: 22/10/2012
• Primary sponsor: Richard Liebano - São Paulo, SP, Brazil
• Public title: Effects of electrical stimulation for reduction of pain, walking ability and respiratory function in kidney donors
• Scientific title: Effects of transcutaneous electrical nerve stimulation on pain, mobility and pulmonary function in kidney donors
• Date of first enrolment: 22/06/2012
• Target sample size: 74
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-8xtkjp/
• Study design: Randomized clinical trial, parallel, 2 arms, double blind, focus treatment

Countries of recruitment

Brazil

Contacts

• Name: Maria Guedes
• Affiliation: Comitê de Ética em Pesquisa

• Name: Ari Santos
• Affiliation: IC-FUC RS

Key inclusion & exclusion criteria

Inclusion criteria: Patients undergoing cardiac surgery with cardiopulmonary bypass,age of 18-65 years.
Exclusion criteria: Non-elective surgery, weigh less than 50 or more than 100 kg,history of psychiatric disorder,ASA physics status of class IV, patients with a mental impairment, knowledge about allergy to studied drugs, patients with congenital cardiac disease and the patients that don't give informed consent.

Age minimum: 18Y
Age maximum: 75Y
Gender: -

Health Condition(s) or Problem(s) studied

Pain, reduction of mobility and pulmonary function in Kidney donors
H02.403.810.803

Intervention(s)

Seventy-four kidney donors will be randomly allocated into 2 groups: Active TENS (n=37) and Placebo TENS (n=37). The transcutaneous electrical nerve stimulation (TENS) will be applied in the surgical incision area for one hour. Frequency will be set at 100 Hz and pulse duration at 100 us. Pulse intensity (amplitude) will be increased until participant report a strong but comfortable paresthesia. In the Placebo TENS group it will be used a modified TENS device that delivers the current for 30 seconds. After this time the amplitude ramps down during 15 seconds until 0 mA. The remaining session keeps without current emission (1 hour). Patients will be followed and submitted to only one application of active or placebo TENS. The application will be performed on the first day of the postoperative period. Evaluations will be held before and after the intervention of TENS. The double-blinding will be done by two evaluators involved with the study, which were trained to perform the procedures in this study. Evaluator 1 will be responsible for the evaluation of pulmonary function (respiratory muscle strength and vital capacity), mobility and assessment of pain intensity in all patients in the study. Evaluator 2 will be responsible for administering TENS in all patients in the study. Only Evaluator 2 will know if the patient received the active or placebo TENS. Both Evaluator 1 and the patients will be blinded to the mode of application of TENS. Evaluator 2 will instruct patients not to report their perceptions during the TENS administration to the evaluator conducting the assessments

Primary Outcome(s)

The effect of midazolam, clonidine and morphine on the systolic arterial pressure in patients undergoing cardiac surgery, on arrival to operating room. On arrival to operating room will be measured the blood pressure (systolic) of patient.

Secondary Outcome(s)

Effects of three drugs on cardiac rate. Will be measured the cardiac rate on arrival to operating room.

Effects of three drugs on level of anxiety. Anxiety will be measured by visual analog scale (VAS), on arrival to operating room.

Effects of three drugs on level of sedation. Sedation will be evaluated by Ramsay Scale.

Effects of three drugs on oxygen saturation level. The arterial oxygen saturation level will be measured by pulse oximeter.

Effects of three drugs on perception of pain caused by arterial and venous puncture. The pain perception will be evaluated by VAS.

Effects of three drugs on recall (amnésia). The amnésia will be evaluated by showing to patients 3 pictures and 3 words, printed on a card. At postoperative period, after awakening, the patients will be queried to recall of the pictures and words.

Effects of three drugs on respiratory rate. The respiratory rate will be measured on arrival to operating room.

Secondary ID(s)

UP.4225/08

Source(s) of Monetary Support

Ari Tadeu Lírio dos Santos - Brazil

Secondary Sponsor(s)

Ari Tadeu Lírio dos Santos - Brazil