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Anorectal Surgery Haemodynamic ChangesNCT02115178

Haemodynamic Effects During Anorectal Surgery: a Comparison of the Jack -Knife and Lithotomy Position

An observational study of Anorectal Surgery Haemodynamic Changes, run by Lithuanian University of Health Sciences at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background and Goal of Study: Minimal dose of spinal hyperbaric bupivacaine is commonly performed for adult anorectal surgery. This kind of anaesthesia can cause sinus bradycardia and hypotension wich reason is body position, autonomic nervus system reaction, reflex reaction even with low levels of sensory block. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Anorectal Surgery Haemodynamic Changes
What is being tested?
Lithotomy or Prone position
How many people
155 participants
Where
1 siteLithuania
Study dates
Aug 2011to Dec 2015
Phase
Observational
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to department of surgery for minor anorectal surgery.

Who may be able to join

  • Adult patient ASA (American Society of Anaesthesiologists) I-IV Surgery in prone position or in lithotomy position Anorectal surgery

Who cannot join

  • inability to give consent to inclusion in trial
  • age less than 18 years
  • the regional anaesthesia is contraindicated
  • the overweight more then 30%
  • taking psychotropic and painkillers to treat chronic diseases
  • the movement of the patients body, including the shivering
Show all 9Show fewer
  • the patients height is the <120 or> 230 cm
  • the patients body weight is <30 or> 155 kg.
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • Department of Anesthesiology, Lithuanian University of Health Sciences

    Kaunas, 50009

Other trials in Lithuania

About this study

Official title: Haemodynamic Effects During Anorectal Surgery in Spinal Anaesthesia With Low Dose Hyperbaric Bupivacaine : a Comparison of the Jack -Knife and Lithotomy Position

Background and Goal of Study: Minimal dose of spinal hyperbaric bupivacaine is commonly performed for adult anorectal surgery. This kind of anaesthesia can cause sinus bradycardia and hypotension wich reason is body position, autonomic nervus system reaction, reflex reaction even with low levels of sensory block. However, neither the publication of minimal doses of spinal hyperbaric bupivacaine effects of haemodynamic modifications nor their accuracy was widely discussed. The aim of the study is to make a comparison of the haemodynamic modifications due to minimal dose of spinal hyperbaric bupivacaine for adult anorectal surgery in lithotomy or jack knife position of steering impedance device.

Materials and Methods: Patients will be included which are over then 18 years old, who underwent anorectal surgery of the benign pathology, requiring spinal anaesthesia, were admitted in this clinical randomized study, hospitalized in Hospital of Lithuanian University of Health Sciences Kaunas Clinics and agree to participate to this study (written settlement). All patients were implicitly divided in to 4 groups by the position will be operating (lithotomy or jack knife position and by American Society of Anaesthesiologists (ASA) clas I-II and III-IV). Technique of anaesthesia were strictly standardized by protocol. All patients were premedicated with oral diazepam 5mg and diclofenac 100mg 60min before operation. After arrival in the operating theater peripheral vein 18 or 20G catheter was inserted, infusion therapy were started with crystalloid 5-7ml/kg/hour. Standard monitoring was used, including noninvasive arterial blood pressure (BP), electrocardiography (ECG), heart rate, peripheral oxygenation. Circulatory changes were recorded impedance device. 2 single-neck sensors connected vertically on both sides of the neck just below the ears lobe. Another pair of sensors attached on both sides of the chest processus xiphoid axillary line level. Thorax allows a variable electrical current, it travels through the lowest resistance (blood-filled aorta) and resistance is measured. For each heart contraction during changes in blood volume and velocity. Accordingly, replacing the resistors obtained by impedance settings.

Read more

Haemodynamic variables were recorded in patients in the use of impedance cardiograph:

  1. arrives in the operating room;
  2. seating on the operating table;
  3. following the puncture;
  4. 10 min after spinal puncture;
  5. was laid in lithotomy or jack knife position;
  6. in the beginning and the end of the operation;
  7. patient was placed in the bed.

Each measurement was monitoring and recorded the following data( ar findings):

  • Cardiac output (CO);
  • Systemic vascular resistance (SVR);
  • Systolic index (SI)
  • Cardiac index (CI);
  • Acceleration index (ACI);
  • Heart rate (HR);
  • Non-invasive systolic (SAP), diastolic (DAP) and mean (MAP) blood pressure;
  • Peripheral oxygenation (SpO2); Patients were placed in the sitting position on the slab (operating table) back to the doctor. Dural puncture was made at L3-L4 or L4-L5 with 27G Tamanho spinal needle ( BBraun, Germany) by medial punction in aseptic condition, before the punction was injected lidocaine 1% subcutaneous. 0.5% 4mg of heavy bupivacaine and 0.01% 10µg fentanyl were injected over 2 minutes after free flow of cerebrospinal fluid was obtained. After sitting for 10 minutes ( sensory block was checked by the dermatomes with the methods of cold sensitivity) patients were asked to lie in the position wich operation will be done (lithotomy or jack knife position).

After 20 min. surgery was started. When anaesthesia was imperfect, 25-100µg of fentanyl was given IV. General anaesthesia will be give in case of failure . These cases will be value like a failure, patients will be exclude from the study.

Clinically significant hypotension will be define as a mean arterial blood pressure and heart rate decrease of 20% below baseline values. Systolic arterial blood pressure will reduce to 90mmHG limit, intravenous ephedrine 5-10 mg will be injected. If heart rate will reduce to 45 bpm, bradycardia will be treated with atropine 0,5 mg IV.

Being tested
Lithotomy or Prone position
Keywords
Hemodynamic changes, Spinal anesthesia, Patient position, Impedance cardiography

What participants receive

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

  • Lithotomy or Prone positionOther

    The surgery, haemodynamic measurements will be performed in Lithotomy or Prone position

Study groups in NCT02115178
Study groupRoleWhat they receive
Lithotomy or Prone positionNot described
Receives: Other: Lithotomy or Prone position

What is being measured

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

  1. Hemodynamic changes

    Hemodynamics measurements using non-invasive impedance cardiography device (BP, HR, SpO2, Cardiac Index, cardiac output, stroke volume, systemic vascular resistance)

    Measured: During anaesthesia and surgery

Timeline

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

  1. First posted15 Apr 2014 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2015
  4. Study completionDec 2015

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02115178
Sponsor's protocol ID
LT22552
Other IDs
JUR2009
Status last verified
Apr 2016
First submitted
9 Apr 2014
Last updated
12 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Borodiciene J, Gudaityte J, Macas A. Lithotomy versus jack-knife position on haemodynamic parameters assessed by impedance cardiography during anorectal surgery under low dose spinal anaesthesia: a randomized controlled trial. BMC Anesthesiol. 2015 May 6;15:74. doi: 10.1186/s12871-015-0055-3.

    PubMed 25943374

Questions about this trial

What is this clinical trial studying?

An observational study of Anorectal Surgery Haemodynamic Changes, run by Lithuanian University of Health Sciences at 1 site in Lithuania.

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 9 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 12 Apr 2016. 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 Lithuania. 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?

Hemodynamic changes (time frame: During anaesthesia and 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 NCT02115178, which also lists 1 linked publication.

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 12 Apr 2016.

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