Ignite Creation Date:
2024-05-06 @ 2:44 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02115178
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2014-04-09
Brief Title:
Haemodynamic Effects During Anorectal Surgery a Comparison of the Jack -Knife and Lithotomy Position
Sponsor:
Lithuanian University of Health Sciences
Organization:
Lithuanian University of Health Sciences
Study Overview
Official Title:
Haemodynamic Effects During Anorectal Surgery in Spinal Anaesthesia With Low Dose Hyperbaric Bupivacaine a Comparison of the Jack -Knife and Lithotomy Position
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 5-7mlkghour 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
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 05 4mg of heavy bupivacaine and 001 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 05 mg IV
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 5-7mlkghour 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
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 05 4mg of heavy bupivacaine and 001 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 05 mg IV
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JUR2009 | REGISTRY | JUR2009 | None |