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Pain, PostoperativePhase 4GALOFFNCT02953210

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

A Phase 4 study testing dexter ketamine, Lidocaine Hydrochloride and Fentanyl Hydrochloride in people with Pain, Postoperative and Anesthesia Complication, run by Federal University of São Paulo at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 70 years
What is being tested?
dexter ketamine, Lidocaine Hydrochloride and Fentanyl Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesBrazil
Study dates
Nov 2016to Mar 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient under Laparoscopic cholecystectomy routine American Society of Anesthesiology ASA I or II

Who cannot join

  • chronic use of opioids
  • Body mass index (BMI) > 35 Kg.m-2
  • Chronic heart failure, renal and hepatic failure
  • illicit drugs users
  • cognitive impairments

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    São Paulo, São Paulo, 01221-020

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    São Paulo, São Paulo, 01333000

Other trials in Brazil

About this study

Official 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

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.

Read the detailed 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.

Being tested
dexter ketamine, Lidocaine Hydrochloride, Fentanyl Hydrochloride, Clonidine Hydrochloride, Midazolam Hydrochloride
Medical subject headings
Pain, Postoperative, Nausea, Vomiting, Ileus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexter ketamineDrug

    Also called ketamine plus

    multimodal anesthesia without opioids ketamine as induction drug

  • Lidocaine HydrochlorideDrug

    Also called xylocaine

    continuous infusion intravenous

  • Fentanyl HydrochlorideDrug

    Also called Fentanil

    intravenous

  • Clonidine HydrochlorideDrug

    Also called Catapres

    clonidine intravenous pre induction

  • Midazolam HydrochlorideDrug

    premedication

  • Isoflurane Volatile LiquidDrug

    Also called isoflurane

    maintenance of general anesthesia

  • Rocuronium Injectable SolutionDrug

    Also called rocuronium

    induction of general anesthesia

  • Propofol 1 % Injectable SuspensionDrug

    Also called propofol

    induction of general anesthesia

  • Dexamethasone-21-Sulfobenzoate, Sodium SaltDrug

    at the end of the procedure 4mg IV

  • Ranitidine HydrochlorideDrug

    at the end of the procedure

  • Ondansetron HydrochlorideDrug

    Also called ondasetron

    at the end of the procedure

  • Ketorolac Injectable SolutionDrug

    Also called keterolac

    at the of the procedure

  • Bupivacaine HydrochlorideDrug

    Also called bupivacaine

    at the end of the procedure for infiltration of trocar wounds

Study groups in NCT02953210
Study groupRoleWhat they receive
GF general freeExperimentalpre 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
Receives: Drug: dexter ketamine; Drug: Lidocaine 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
GBal general balancedActive comparatorpre 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
Receives: Drug: Fentanyl 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative pain

    will be asked pain at rest and movement and cough using the analog verbal scale of pain

    Measured: 60min after the surgery

Secondary outcomes (14)

  1. nausea/ vomiting

    will be asked yes or not and how many times

    Measured: 12, 24 and 36 hours after surgery

  2. Paralytic ileus

    will be access with ultrasound movement of intestine

    Measured: 12, 24 and 36 hours after surgery

  3. first analgesic rescue requirement

    the first analgesic given at PACU when the patient asked for it

    Measured: 12 hours after the surgery

  4. pruritus

    yes or no, mild, moderate to serve

    Measured: 12, 24 , 36 hours after surgery

  5. sedation

    will be use the Ramasay scale

    Measured: 12, 24 and 26 hours after surgery

  6. time of discharge of PACU

    time when the patient will transfer to ward after the surgery

    Measured: 12 hour after the surgery

  7. Hemodynamics effects

    mean arterial pressure

    Measured: intraoperative

  8. weight

    measure in kilogram

    Measured: Baseline

  9. height

    measure in cm

    Measured: Baseline

  10. gender

    male or female

    Measured: Baseline

  11. saturation of o2

    oximetry

    Measured: intraoperative

  12. ETCO2

    capnography

    Measured: intraoperative

  13. heart rate

    heart rate

    Measured: intraoperative

  14. pain

    will be asked pain at rest and movement and cough using the analog verbal scale of pain

    Measured: 12, 24 and 36 hours after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionNov 2016 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02953210
Sponsor's protocol ID
opioid free anesthesia
Acronym
GALOFF
Status last verified
Nov 2016
First submitted
26 Oct 2016
Last updated
4 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. doi: 10.1097/00000542-200604000-00030.

    PubMed 16571981

  • 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.

    PubMed 22584558

  • 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(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02.

    PubMed 17959952

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dexter ketamine, Lidocaine Hydrochloride and Fentanyl Hydrochloride in people with Pain, Postoperative and Anesthesia Complication, run by Federal University of São Paulo at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pain (time frame: 60min after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953210, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.

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