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Incidence of Postoperative Delirium in Cancer Patients After Laparoscopic Surgery in Trendelenburg Position

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03572517
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
AC Camargo Cancer Center

Brief Summary:

Postoperative delirium is an acute mental syndrome that is caused by diffuse cerebral dysfunction resulting from the action of predisposing and precipitating factors acting together. It is associated with an increase in mortality and postoperative morbidity and prolongs the period of hospitalization of the patient Videolaparoscopic surgery has been increasingly used as a therapeutic and diagnostic method. In order to have a good visualization of the anatomical structures on which it will act, it is necessary to introduce gas into the cavity, a mandatory component known as pneumoperitoneum. This technique gives special characteristics for the conduction of anesthesia, since the positive intra-abdominal pressure results in changes in the patient's physiology. Some types of laparoscopic surgery require the position of Trendelenburg for better visualization of the operative field. Among the changes related to this position are the increase in cardiac output and intracranial pressure.

In order to optimize the anesthetic procedure, anesthetic blocks have been increasingly used, especially the spinal. The association of general anesthesia with spinal anesthesia, followed by its contraindications is advantageous, because lower doses of anesthetic agents are necessary for the maintenance of general anesthesia. This association results in an earlier awakening, a reduction of nausea / vomiting, postoperative pain, length of hospital stay, cost effectiveness and greater patient satisfaction. As a disadvantage, by associating general anesthesia with spinal anesthesia, patients become susceptible to the adverse events of spinal anesthesia. Among these, the most common are headache, hypotension, nausea and vomiting, pruritus, urinary retention and tremor. Performing spinal anesthesia with opioids alone, without the use of local anesthetic is also possible, with morphine being the most used. The benefit of this variation of technique is analgesia for a period of 12 to 24 hours, without the cardiovascular consequences resulting from the action of the local anesthetic.

JUSTIFICATION: There are no studies in the literature evaluating The objective of this study is to analyze if the anesthetic techniques employed, general anesthesia or general anesthesia associated with subarachnoid block, for videolaparoscopic oncologic surgeries, in Trendelenburg position, differ in relation to the incidence of delirium in the postoperative period.


Condition or disease Intervention/treatment Phase
Delirium Anesthesia Procedure: Subarachnoid block Procedure: Spinal morphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be allocated sequentially in 2 groups. Sequential allocation will be used in order to control age as a possible confounding factor for the outcome of interest. The randomization will be performed through free software R version 3.4.

  1. Balanced general anesthesia.
  2. Balanced general anesthesia associated with subarachnoid block with 0.5% heavy bupivacaine (3ml).

All patients will receive morphine 50 mcg via the spinal route.

Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Comparison of Two Different Anesthetic Techniques on Incidence of Postoperative Delirium in Cancer Patients After Laparoscopic Surgery in Trendelenburg Position: A Prospective Randomized Clinical Trial
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : September 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: Subarachnoid block

Subarachnoid block with hyperbaric bupivacaine 0,5% 3ml associate with morphine 50 mcg.

A general anesthetic with fentanyl 3 mcg / kg + propofol 2 mg / kg + rocuronium 0.6 mg / kg will be performed.

Anesthesia will be maintained with remifentanil (ng / ml) through Minto's pharmacokinetic model (BBraun infusion syringe - Perfusor® Space model) and desflurane (Fe%).

Procedure: Subarachnoid block
Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) associated with subarachnoid block (bupivacaine and morphine)

Active Comparator: Spinal morphine

Spinal morphine with morphine 50 mcg. A general anesthetic with fentanyl 3 mcg / kg + propofol 2 mg / kg + rocuronium 0.6 mg / kg will be performed.

Anesthesia will be maintained with remifentanil (ng / ml) through Minto's pharmacokinetic model (BBraun infusion syringe - Perfusor® Space model) and desflurane (Fe%).

Procedure: Spinal morphine
Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) and spinal analgesia with morphine




Primary Outcome Measures :
  1. Confusion Assessment Method in association with Richmond Agitation Sedation Scale will be used to postoperative delirium diagnosis. [ Time Frame: Until discharge from hospital (an average of 3 days) ]

    Confusion Assessment Method: presence or absence of delirium

    If present should be classified

    Richmond Agitation Sedation Scale (positive):4 Combative; 3 Very agitated; 2 Agitated;1 Restless 0 Alert and calm (negative):1Drowsy;2 Light sedation; 3 Moderate sedation;4 Deep sedation;5 Unarousable

    (positive) delirium hyperactive (negative) delirium hypoactive



Secondary Outcome Measures :
  1. Numeric Pain Rating Scale will be used to evaluate pain. [ Time Frame: Until discharge from hospital (an average of 3 days) ]
    Postoperative pain Number scale from 0 (minimum level of pain) to 10 (higher level of pain)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Oncologic patients submitted to elective videolaparoscopic surgery in Trendelenburg position
  • 18 years or older
  • ASA lesser than 3
  • period of at least 2 hours in Trendelenburg position

Exclusion Criteria:

  • With absolute contraindication and related to spinal anesthesia
  • With difficult airway prediction with possibility of awake intubation.
  • With previous diagnosis of: cognitive disorder and / or depression.
  • Chronic use of benzodiazepines (use during the last 12 weeks).
  • Referred to perform the postoperative ICU.
  • With diagnosis of anemia (Hemoglobin <10).
  • With diagnosis of current infection.
  • With renal disease with stage> G3a (glomerular filtration rate <45 ml / min / 1.73 m2.
  • With body mass index (BMI) characterized by obesity (BMI> 30 kg / m2).
  • With history of nausea / vomiting in previous anesthetic procedures.
  • With diagnosis of malignant hyperthermia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572517


Locations
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Brazil
A.C. Camargo Cancer Center
São Paulo, Brazil, 01509010
Sponsors and Collaborators
AC Camargo Cancer Center
Investigators
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Study Chair: Giane Nakamura A.C. Camargo Cancer Center
Publications:

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Responsible Party: AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT03572517    
Other Study ID Numbers: 2205/16
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AC Camargo Cancer Center:
Delirium
Anesthesia
Surgical Oncology
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents