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.
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
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:
- arrives in the operating room;
- seating on the operating table;
- following the puncture;
- 10 min after spinal puncture;
- was laid in lithotomy or jack knife position;
- in the beginning and the end of the operation;
- 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.
- Conditions
- Anorectal Surgery Haemodynamic Changes
- 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 group | Role | What they receive |
|---|---|---|
| Lithotomy or Prone position | Not described Receives: Other: Lithotomy or Prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted15 Apr 2014 (estimated)
- Study startAug 2011
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorectal Surgery Haemodynamic ChangesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgita Borodiciene, Lithuanian University of Health Sciences
- Investigators
- Jurate Gudaityte, Assoc. Prof., Study chair, Department of Anaesthesiology,Lithuanian University of Health Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Effects During Anorectal Surgery in Spinal Anaesthesia With Low Dose Hyperbaric Bupivacaine : a Comparison of the Jack -Knife and Lithotomy Position
- ClinicalTrials.gov ID
- NCT02115178
- Acronym / sponsor ID
- LT22552
- Conditions
- Anorectal Surgery Haemodynamic Changes
- Keywords
- Hemodynamic changes, Spinal anesthesia, Patient position, Impedance cardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Apr 2014 (estimated)
- 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.
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.
Haemodynamic variables were recorded in patients in the use of impedance cardiograph:
- arrives in the operating room;
- seating on the operating table;
- following the puncture;
- 10 min after spinal puncture;
- was laid in lithotomy or jack knife position;
- in the beginning and the end of the operation;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithotomy or Prone position | – | Other: Lithotomy or Prone position |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to department of surgery for minor anorectal surgery.
Key inclusion criteria (1 listed)
- Adult patient ASA (American Society of Anaesthesiologists) I-IV Surgery in prone position or in lithotomy position Anorectal surgery
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Lithotomy or Prone positionThe surgery, haemodynamic measurements will be performed in Lithotomy or Prone position | Other | Lithotomy or Prone position |
Primary outcome
Hemodynamic changes
Time frame: During anaesthesia and surgery
Hemodynamics measurements using non-invasive impedance cardiography device (BP, HR, SpO2, Cardiac Index, cardiac output, stroke volume, systemic vascular resistance)
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 12 Apr 2016.
- Derived from this study: PubMed 25943374Borodiciene 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.
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.
Jurate Gudaityte, Assoc. Prof. study chair
Department of Anaesthesiology,Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
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.