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

NCT03572517 | Completed DMC

• 1 other identifier: 2205/16
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Anesthesia

Keywords

Delirium; Anesthesia; Surgical Oncology

Outcome Measures

Primary Outcomes (1)

• Confusion Assessment Method in association with Richmond Agitation Sedation Scale will be used to postoperative delirium diagnosis.

  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

  Until discharge from hospital (an average of 3 days)

Secondary Outcomes (1)

• Numeric Pain Rating Scale will be used to evaluate pain.

  Until discharge from hospital (an average of 3 days)

Study Arms (2)

Subarachnoid block

ACTIVE COMPARATOR

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

Spinal morphine

ACTIVE COMPARATOR

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

Interventions

Subarachnoid block PROCEDURE

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

Subarachnoid block

Spinal morphine PROCEDURE

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

Spinal morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

A.C. Camargo Cancer Center

São Paulo, 01509010, Brazil

Location

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MeSH Terms

Conditions

Delirium

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Giane Nakamura

  A.C. Camargo Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: June 28, 2018
• Study Start: September 1, 2017
• Primary Completion: June 25, 2018
• Study Completion: September 25, 2018
• Last Updated: September 16, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)