Pain, Postoperative Clinical Trial
— GALOFFOfficial title:
Comparative Randomized Controlled Trial Study of General Balanced Anesthesia Based on Opioid and Opioid Sparing Balanced Anesthesia for Cholecystectomy Surgery Via Laparoscopy: Intraoperative and Postoperative Outcomes
Verified date | November 2016 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The use of opioid during surgery can cause side effects and may delay hospital discharge. Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and and the time of discharge. In this compared controlled randomized study the aim is to evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting, postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia care unit and hospital.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | March 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patient under Laparoscopic cholecystectomy routine American Society of Anesthesiology ASA I or II Exclusion Criteria: - chronic use of opioids - Body mass index (BMI) > 35 Kg.m-2 - Chronic heart failure, renal and hepatic failure - illicit drugs users - cognitive impairments |
Country | Name | City | State |
---|---|---|---|
Brazil | Faculdade de Ciências Médicas da Santa Casa de São Paulo | Sao Paulo | |
Brazil | Faculdade de Ciências Médicas da Santa Casa de São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Faculdade de Ciências Médicas da Santa Casa de São Paulo |
Brazil,
Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. Review. — View Citation
Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105( — View Citation
De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative pain | will be asked pain at rest and movement and cough using the analog verbal scale of pain | 60min after the surgery | |
Secondary | nausea/ vomiting | will be asked yes or not and how many times | 12, 24 and 36 hours after surgery | |
Secondary | Paralytic ileus | will be access with ultrasound movement of intestine | 12, 24 and 36 hours after surgery | |
Secondary | first analgesic rescue requirement | the first analgesic given at PACU when the patient asked for it | 12 hours after the surgery | |
Secondary | pruritus | yes or no, mild, moderate to serve | 12, 24 , 36 hours after surgery | |
Secondary | sedation | will be use the Ramasay scale | 12, 24 and 26 hours after surgery | |
Secondary | time of discharge of PACU | time when the patient will transfer to ward after the surgery | 12 hour after the surgery | |
Secondary | Hemodynamics effects | mean arterial pressure | intraoperative | |
Secondary | weight | measure in kilogram | Baseline | |
Secondary | height | measure in cm | Baseline | |
Secondary | gender | male or female | Baseline | |
Secondary | saturation of o2 | oximetry | intraoperative | |
Secondary | ETCO2 | capnography | intraoperative | |
Secondary | heart rate | heart rate | intraoperative | |
Secondary | pain | will be asked pain at rest and movement and cough using the analog verbal scale of pain | 12, 24 and 36 hours after the procedure |
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