Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane 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.

Official Title
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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

Conditions
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Pain, Postoperative, Anesthesia Complication, Nausea, Vomiting, Ileus Paralytic, Hemodynamic Instability

Intervention / Treatment
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* Drug: dexter ketamine
* Drug: Lidocaine Hydrochloride
* Drug: Fentanyl Hydrochloride
* Drug: Clonidine Hydrochloride
* Drug: Midazolam Hydrochloride
* Drug: Isoflurane Volatile Liquid
* Drug: Rocuronium Injectable Solution
* Drug: Propofol 1 % Injectable Suspension
* Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt
* Drug: Ranitidine Hydrochloride
* Drug: Ondansetron Hydrochloride
* Drug: Ketorolac Injectable Solution
* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GF general free<br>pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h | Drug: dexter ketamine<br>* multimodal anesthesia without opioids ketamine as induction drug<br>* Other names: ketamine plus;Drug: Lidocaine Hydrochloride<br>* continuous infusion intravenous<br>* Other names: xylocaine;Drug: Clonidine Hydrochloride<br>* clonidine intravenous pre induction<br>* Other names: Catapres;Drug: Midazolam Hydrochloride<br>* premedication<br>Drug: Isoflurane Volatile Liquid<br>* maintenance of general anesthesia<br>* Other names: isoflurane;Drug: Rocuronium Injectable Solution<br>* induction of general anesthesia<br>* Other names: rocuronium;Drug: Propofol 1 % Injectable Suspension<br>* induction of general anesthesia<br>* Other names: propofol;Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt<br>* at the end of the procedure 4mg IV<br>Drug: Ranitidine Hydrochloride<br>* at the end of the procedure<br>Drug: Ondansetron Hydrochloride<br>* at the end of the procedure<br>* Other names: ondasetron;Drug: Ketorolac Injectable Solution<br>* at the of the procedure<br>* Other names: keterolac;Drug: Bupivacaine Hydrochloride<br>* at the end of the procedure for infiltration of trocar wounds<br>* Other names: bupivacaine;|
| Active Comparator: GBal general balanced<br>pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed | Drug: Fentanyl Hydrochloride<br>* intravenous<br>* Other names: Fentanil;Drug: Midazolam Hydrochloride<br>* premedication<br>Drug: Isoflurane Volatile Liquid<br>* maintenance of general anesthesia<br>* Other names: isoflurane;Drug: Rocuronium Injectable Solution<br>* induction of general anesthesia<br>* Other names: rocuronium;Drug: Propofol 1 % Injectable Suspension<br>* induction of general anesthesia<br>* Other names: propofol;Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt<br>* at the end of the procedure 4mg IV<br>Drug: Ranitidine Hydrochloride<br>* at the end of the procedure<br>Drug: Ondansetron Hydrochloride<br>* at the end of the procedure<br>* Other names: ondasetron;Drug: Ketorolac Injectable Solution<br>* at the of the procedure<br>* Other names: keterolac;Drug: Bupivacaine Hydrochloride<br>* at the end of the procedure for infiltration of trocar wounds<br>* Other names: bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | will be asked pain at rest and movement and cough using the analog verbal scale of pain | 60min after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea/ vomiting | will be asked yes or not and how many times | 12, 24 and 36 hours after surgery | 
| Paralytic ileus | will be access with ultrasound movement of intestine | 12, 24 and 36 hours after surgery | 
| first analgesic rescue requirement | the first analgesic given at PACU when the patient asked for it | 12 hours after the surgery | 
| pruritus | yes or no, mild, moderate to serve | 12, 24 , 36 hours after surgery | 
| sedation | will be use the Ramasay scale | 12, 24 and 26 hours after surgery | 
| time of discharge of PACU | time when the patient will transfer to ward after the surgery | 12 hour after the surgery | 
| Hemodynamics effects | mean arterial pressure | intraoperative | 
| weight | measure in kilogram | Baseline | 
| height | measure in cm | Baseline | 
| gender | male or female | Baseline | 
| saturation of o2 | oximetry | intraoperative | 
| ETCO2 | capnography | intraoperative | 
| heart rate | heart rate | intraoperative | 
| 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 |