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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02953210
Other study ID # opioid free anesthesia
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received October 26, 2016
Last updated November 3, 2016
Start date November 2016
Est. completion date March 2017

Study information

Verified date November 2016
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Patients under laparoscopic cholecystectomy has moderate to severe pain. This study will compare intraoperative hemodynamic parameters under two techniques of general anesthesia: The primary outcome pain was used for planning the sample size of participants and considered a variation of 3 points on VAS (Visual analogic scale of pain). The secondaries outcomes nausea/vomiting, sedation, ileus paralytics, urinary retention, time of discharge (PACU) and hospital stay, and patient satisfaction will be recorded and analyzed.

the patients will be allocated from randomized program in one of the two arms.

1. Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane

2. Opioid sparing balance anesthesia with propofol, dexter- ketamine, clonidine, midazolan,isoflurane and lidocaine.

At the end of procedure both groups will receive dexamethasone, ranitidine

, ondansetron, keterolac IV and local infiltration of bupivacaine on trocar wounds as multimodal analgesia.

General anesthesia opioid free seems to have less side effects than the general anesthesia based on opioid this study will compare it.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
dexter ketamine
multimodal anesthesia without opioids ketamine as induction drug
Lidocaine Hydrochloride
continuous infusion intravenous
Fentanyl Hydrochloride
intravenous
Clonidine Hydrochloride
clonidine intravenous pre induction
Midazolam Hydrochloride
premedication
Isoflurane Volatile Liquid
maintenance of general anesthesia
Rocuronium Injectable Solution
induction of general anesthesia
Propofol 1 % Injectable Suspension
induction of general anesthesia
Dexamethasone-21-Sulfobenzoate, Sodium Salt
at the end of the procedure 4mg IV
Ranitidine Hydrochloride
at the end of the procedure
Ondansetron Hydrochloride
at the end of the procedure
Ketorolac Injectable Solution
at the of the procedure
Bupivacaine Hydrochloride
at the end of the procedure for infiltration of trocar wounds

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Outcome

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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