DeliriumNCT03572517
Incidence of Postoperative Delirium in Cancer Patients After Laparoscopic Surgery in Trendelenburg Position
A study testing Subarachnoid block and Spinal morphine in people with Delirium and Anesthesia, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Anesthesia
- What is being tested?
- Subarachnoid block and Spinal morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2017to 25 Sep 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
These patients will be monitored intraoperatively with electrocardiogram (ECG), noninvasive pressure, pulse oximetry, capnography, BIS, monitor of neuromuscular blocker (TOF), esophageal temperature and Trendelenburg angle.
The measured moments will be patient entry in the operating room, after pre-anesthetic medication, anesthetic pre-induction, after anesthetic induction, after surgical incision, after pneumoperitoneum infusion, after Trendelenburg position, every 15 minutes until the end of the procedure and after extubation.
All patients will receive morphine 50 mcg via the spinal route. All patients will receive intravenous pre-anesthetic medication midazolam 0.03 mg / kg for comfort during spinal anesthesia and 500 ml of crystalloid solution prior to blockade associated with 4 ml / kg / hour of crystalloid solution plus volume to be depended of clinical parameters.
Subarachnoid block will be performed in the seated position, antisepsis / asepsis with alcoholic chlorhexidine, location of the L3 / L4 space, needle puncture with whitacre 27 G, barbotation of 0.5 ml and injection lasting 5 to 7 seconds.
Spinal morphine will be performed with the same anesthetic technique described in the subarachnoid block.
A general anesthetic with pre-oxygenation 8 liters / minute for 5 minutes + fentanyl 3 mcg / kg + propofol 2 mg / kg + rocuronium 0.6 mg / kg will be performed. Patients will be ventilated with a mixture of oxygen and air through an inspired fraction of 40% oxygen and maintaining an expired concentration of carbon dioxide between 35 and 45 mmHg. Anesthesia will be maintained with remifentanil (ng / ml) through Minto's pharmacokinetic model (BBraun infusion syringe - Perfusor® Space model) and desflurane (Fe%).
Hypnosis will be guided by maintaining BIS between 40 and 60 and the dose of remifentanil will be adjusted by vital signs.
Patients with medium arterial pressure with values lower than 60 mmHg will be medicated with vasopressors depending on heart rate. If heart rate is greater than 60 beats per minute (bpm) metaraminol 0.5 mg will be used and 5 mg ephedrine will be used if heart rate less than 60 bpm.
In both groups, the patients will be kept warm with a thermal blanket and will have their esophageal temperature measured (40 cm from the incisor teeth).
After the surgical procedure, neuromuscular blockade will be antagonized with suggamadex, according to the monitoring of neuromuscular blockade through TOF.
- Deep block (at least 1 to 2 responses in PTC, but prior to the appearance of T2, ie the second response to TOF): 4 mg / kg.
- Moderate block (after onset of T2): 2mg / kg.
- 16 mg / kg is recommended if there is a clinical condition requiring rapid reversal (approximately 3 minutes) following the single dose of rocuronium at 1.2 mg / kg.
After 5 minutes of extubation, vital signs (blood pressure, heart rate, saturation) will be collected and the patient will be evaluated for the presence of delirium. Dipyrone 2 grams and parecoxib 40 mg will be performed without contraindication for postoperative analgesia.
Patients will then be referred to the anesthetic recovery room, where they will continue to be monitored with ECG, noninvasive pressure and pulse oximeters. They will also be evaluated for pain in the numerical estimate scale (NRS) (0 = no pain, up to 10 = maximum pain), on arrival and every 30 minutes until the time of discharge into the room. Those who present pain with NRS greater than 4 in PACU will be treated with morphine 1 mg every 10 minutes. Those with nausea / vomiting will be given alizapride 50 mg.
Patients will be assessed with regard to the appearance of delirium by means of CAM (Confusion Assemption Method) in association with the Richmond Agitation Sedation Scale (RASS) scale.
CAM is a simple screening method based on the following four questions, with Criteria 1 and 2 plus 3 or 4 being present:
- Acute onset: Is there evidence of acute change in the patient's underlying mental state?
- Attention Disorder: Has the patient had difficulty focusing on his or her attention, for example, was easily distracted or had difficulty following what was being said?
- Disorganized thinking: Was the patient's thinking disorganized or incoherent, with dispersive or irrelevant conversion, unclear or illogical flow of ideas, or unpredictable change of subject?
- Changes in level of consciousness: Does the patient present altered level of consciousness such as lethargy, torporous, comatose? The RASS, was developed with the purpose of characterizing the level of consciousness and agitation. Signs of hyperactive delirium are defined as scores ranging from +1 (anxious patient), +2 (frequent uncoordinated unintentional movements, fight against ventilation), +3 (aggressive) to +4 (very aggressive). Signs of hypoactive delirium are defined as RASS ranging from - 5 (patient does not respond), - 4 (no response to voice sound), -3 (movements or ocular opening to voice sound), -2 (awakens briefly), - 1 (not completely alert) to 0 (patient calm or sleepy).
This evaluation will be performed by nurses, previously trained, on arrival at PACU every 30 minutes until discharge from the post-anesthetic recovery room and 24 hours after the patient's discharge from the hospital. In cases where the patient has an episode of persistent delirium for more than 1 hour, the evaluation of a psychiatrist will be requested for follow-up and treatment.
- Conditions
- Delirium, Anesthesia
- Being tested
- Subarachnoid block, Spinal morphine
- Keywords
- Delirium, Anesthesia, Surgical Oncology
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subarachnoid blockProcedure or surgery
Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) associated with subarachnoid block (bupivacaine and morphine)
Spinal morphineProcedure or surgery
Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) and spinal analgesia with morphine
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: 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%). Receives: Procedure: Spinal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until discharge from hospital (an average of 3 days)
Secondary outcomes (1)
Numeric Pain Rating Scale will be used to evaluate pain.
Postoperative pain Number scale from 0 (minimum level of pain) to 10 (higher level of pain)
Measured: Until discharge from hospital (an average of 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start1 Sep 2017
- Primary completion25 Jun 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giane Nakamura, Study chair, A.C. Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572517
- Sponsor's protocol ID
- 2205/16
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Absalom AR, Glen JI, Zwart GJ, Schnider TW, Struys MM. Target-Controlled Infusion: A Mature Technology. Anesth Analg. 2016 Jan;122(1):70-8. doi: 10.1213/ANE.0000000000001009.
PubMed 26516798Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
PubMed 28187050Ali HH, Utting JE, Gray C. Stimulus frequency in the detection of neuromuscular block in humans. Br J Anaesth. 1970 Nov;42(11):967-78. doi: 10.1093/bja/42.11.967. No abstract available.
PubMed 5488360Ali S, Patel M, Jabeen S, Bailey RK, Patel T, Shahid M, Riley WJ, Arain A. Insight into delirium. Innov Clin Neurosci. 2011 Oct;8(10):25-34.
PubMed 22132368American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
PubMed 25535170American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789Apfel CC, Kranke P, Katz MH, Goepfert C, Papenfuss T, Rauch S, Heineck R, Greim CA, Roewer N. Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design. Br J Anaesth. 2002 May;88(5):659-68. doi: 10.1093/bja/88.5.659.
PubMed 12067003Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
PubMed 23364566Araimo Morselli FSM, Zuccarini F, Caporlingua F, Scarpa I, Imperiale C, Caporlingua A, De Biase L, Tordiglione P. Intrathecal Versus Intravenous Morphine in Minimally Invasive Posterior Lumbar Fusion: A Blinded Randomized Comparative Prospective Study. Spine (Phila Pa 1976). 2017 Mar;42(5):281-284. doi: 10.1097/BRS.0000000000001733.
PubMed 27306255Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
PubMed 24635770Barrio J, Errando CL, San Miguel G, Salas BI, Raga J, Carrion JL, Garcia-Ramon J, Gallego J. Effect of depth of neuromuscular blockade on the abdominal space during pneumoperitoneum establishment in laparoscopic surgery. J Clin Anesth. 2016 Nov;34:197-203. doi: 10.1016/j.jclinane.2016.04.017. Epub 2016 May 11.
PubMed 27687373Bartels K, Esper SA, Thiele RH. Blood Pressure Monitoring for the Anesthesiologist: A Practical Review. Anesth Analg. 2016 Jun;122(6):1866-79. doi: 10.1213/ANE.0000000000001340.
PubMed 27195632Bessa SS, Katri KM, Abdel-Salam WN, El-Kayal el-SA, Tawfik TA. Spinal versus general anesthesia for day-case laparoscopic cholecystectomy: a prospective randomized study. J Laparoendosc Adv Surg Tech A. 2012 Jul-Aug;22(6):550-5. doi: 10.1089/lap.2012.0110. Epub 2012 Jun 11.
PubMed 22686181Birch DW, Dang JT, Switzer NJ, Manouchehri N, Shi X, Hadi G, Karmali S. Heated insufflation with or without humidification for laparoscopic abdominal surgery. Cochrane Database Syst Rev. 2016 Oct 19;10(10):CD007821. doi: 10.1002/14651858.CD007821.pub3.
PubMed 27760282Borgeat A, Ekatodramis G, Schenker CA. Postoperative nausea and vomiting in regional anesthesia: a review. Anesthesiology. 2003 Feb;98(2):530-47. doi: 10.1097/00000542-200302000-00036. No abstract available.
PubMed 12552215
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03572517
- Acronym / sponsor ID
- 2205/16
- Conditions
- Delirium, Anesthesia
- Keywords
- Delirium, Anesthesia, Surgical Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
These patients will be monitored intraoperatively with electrocardiogram (ECG), noninvasive pressure, pulse oximetry, capnography, BIS, monitor of neuromuscular blocker (TOF), esophageal temperature and Trendelenburg angle.
The measured moments will be patient entry in the operating room, after pre-anesthetic medication, anesthetic pre-induction, after anesthetic induction, after surgical incision, after pneumoperitoneum infusion, after Trendelenburg position, every 15 minutes until the end of the procedure and after extubation.
All patients will receive morphine 50 mcg via the spinal route. All patients will receive intravenous pre-anesthetic medication midazolam 0.03 mg / kg for comfort during spinal anesthesia and 500 ml of crystalloid solution prior to blockade associated with 4 ml / kg / hour of crystalloid solution plus volume to be depended of clinical parameters.
Subarachnoid block will be performed in the seated position, antisepsis / asepsis with alcoholic chlorhexidine, location of the L3 / L4 space, needle puncture with whitacre 27 G, barbotation of 0.5 ml and injection lasting 5 to 7 seconds.
Spinal morphine will be performed with the same anesthetic technique described in the subarachnoid block.
A general anesthetic with pre-oxygenation 8 liters / minute for 5 minutes + fentanyl 3 mcg / kg + propofol 2 mg / kg + rocuronium 0.6 mg / kg will be performed. Patients will be ventilated with a mixture of oxygen and air through an inspired fraction of 40% oxygen and maintaining an expired concentration of carbon dioxide between 35 and 45 mmHg. Anesthesia will be maintained with remifentanil (ng / ml) through Minto's pharmacokinetic model (BBraun infusion syringe - Perfusor® Space model) and desflurane (Fe%).
Hypnosis will be guided by maintaining BIS between 40 and 60 and the dose of remifentanil will be adjusted by vital signs.
Patients with medium arterial pressure with values lower than 60 mmHg will be medicated with vasopressors depending on heart rate. If heart rate is greater than 60 beats per minute (bpm) metaraminol 0.5 mg will be used and 5 mg ephedrine will be used if heart rate less than 60 bpm.
In both groups, the patients will be kept warm with a thermal blanket and will have their esophageal temperature measured (40 cm from the incisor teeth).
After the surgical procedure, neuromuscular blockade will be antagonized with suggamadex, according to the monitoring of neuromuscular blockade through TOF.
- Deep block (at least 1 to 2 responses in PTC, but prior to the appearance of T2, ie the second response to TOF): 4 mg / kg.
- Moderate block (after onset of T2): 2mg / kg.
- 16 mg / kg is recommended if there is a clinical condition requiring rapid reversal (approximately 3 minutes) following the single dose of rocuronium at 1.2 mg / kg.
After 5 minutes of extubation, vital signs (blood pressure, heart rate, saturation) will be collected and the patient will be evaluated for the presence of delirium. Dipyrone 2 grams and parecoxib 40 mg will be performed without contraindication for postoperative analgesia.
Patients will then be referred to the anesthetic recovery room, where they will continue to be monitored with ECG, noninvasive pressure and pulse oximeters. They will also be evaluated for pain in the numerical estimate scale (NRS) (0 = no pain, up to 10 = maximum pain), on arrival and every 30 minutes until the time of discharge into the room. Those who present pain with NRS greater than 4 in PACU will be treated with morphine 1 mg every 10 minutes. Those with nausea / vomiting will be given alizapride 50 mg.
Patients will be assessed with regard to the appearance of delirium by means of CAM (Confusion Assemption Method) in association with the Richmond Agitation Sedation Scale (RASS) scale.
CAM is a simple screening method based on the following four questions, with Criteria 1 and 2 plus 3 or 4 being present:
- Acute onset: Is there evidence of acute change in the patient's underlying mental state?
- Attention Disorder: Has the patient had difficulty focusing on his or her attention, for example, was easily distracted or had difficulty following what was being said?
- Disorganized thinking: Was the patient's thinking disorganized or incoherent, with dispersive or irrelevant conversion, unclear or illogical flow of ideas, or unpredictable change of subject?
- Changes in level of consciousness: Does the patient present altered level of consciousness such as lethargy, torporous, comatose? The RASS, was developed with the purpose of characterizing the level of consciousness and agitation. Signs of hyperactive delirium are defined as scores ranging from +1 (anxious patient), +2 (frequent uncoordinated unintentional movements, fight against ventilation), +3 (aggressive) to +4 (very aggressive). Signs of hypoactive delirium are defined as RASS ranging from - 5 (patient does not respond), - 4 (no response to voice sound), -3 (movements or ocular opening to voice sound), -2 (awakens briefly), - 1 (not completely alert) to 0 (patient calm or sleepy).
This evaluation will be performed by nurses, previously trained, on arrival at PACU every 30 minutes until discharge from the post-anesthetic recovery room and 24 hours after the patient's discharge from the hospital. In cases where the patient has an episode of persistent delirium for more than 1 hour, the evaluation of a psychiatrist will be requested for follow-up and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid block | Active comparator | Procedure: Subarachnoid blockSubarachnoid 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%). |
| Spinal morphine | Active comparator | Procedure: Spinal morphineSpinal 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%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subarachnoid blockBalanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) associated with subarachnoid block (bupivacaine and morphine) | Procedure or surgery | Subarachnoid block |
| Spinal morphineBalanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) and spinal analgesia with morphine | Procedure or surgery | Spinal morphine |
Primary outcome
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
1 secondary outcome
Numeric Pain Rating Scale will be used to evaluate pain.
Time frame: Until discharge from hospital (an average of 3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Background: PubMed 26516798Absalom AR, Glen JI, Zwart GJ, Schnider TW, Struys MM. Target-Controlled Infusion: A Mature Technology. Anesth Analg. 2016 Jan;122(1):70-8. doi: 10.1213/ANE.0000000000001009.
- Background: PubMed 28187050Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
- Background: PubMed 5488360Ali HH, Utting JE, Gray C. Stimulus frequency in the detection of neuromuscular block in humans. Br J Anaesth. 1970 Nov;42(11):967-78. doi: 10.1093/bja/42.11.967. No abstract available.
- Background: PubMed 22132368Ali S, Patel M, Jabeen S, Bailey RK, Patel T, Shahid M, Riley WJ, Arain A. Insight into delirium. Innov Clin Neurosci. 2011 Oct;8(10):25-34.
- Background: PubMed 25535170American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
- Background: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Background: PubMed 12067003Apfel CC, Kranke P, Katz MH, Goepfert C, Papenfuss T, Rauch S, Heineck R, Greim CA, Roewer N. Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design. Br J Anaesth. 2002 May;88(5):659-68. doi: 10.1093/bja/88.5.659.
- Background: PubMed 23364566Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
- Background: PubMed 27306255Araimo Morselli FSM, Zuccarini F, Caporlingua F, Scarpa I, Imperiale C, Caporlingua A, De Biase L, Tordiglione P. Intrathecal Versus Intravenous Morphine in Minimally Invasive Posterior Lumbar Fusion: A Blinded Randomized Comparative Prospective Study. Spine (Phila Pa 1976). 2017 Mar;42(5):281-284. doi: 10.1097/BRS.0000000000001733.
- Background: PubMed 24635770Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
- Background: PubMed 27687373Barrio J, Errando CL, San Miguel G, Salas BI, Raga J, Carrion JL, Garcia-Ramon J, Gallego J. Effect of depth of neuromuscular blockade on the abdominal space during pneumoperitoneum establishment in laparoscopic surgery. J Clin Anesth. 2016 Nov;34:197-203. doi: 10.1016/j.jclinane.2016.04.017. Epub 2016 May 11.
- Background: PubMed 27195632Bartels K, Esper SA, Thiele RH. Blood Pressure Monitoring for the Anesthesiologist: A Practical Review. Anesth Analg. 2016 Jun;122(6):1866-79. doi: 10.1213/ANE.0000000000001340.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giane Nakamura study chair
A.C. Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subarachnoid block and Spinal morphine in people with Delirium and Anesthesia, run by AC Camargo Cancer Center at 1 site 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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)). 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 NCT03572517, which also lists 52 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 16 Sep 2019.