A quantitative analysis of sedation in infants with caudal blockade
Organizational Data
- DRKS-ID:
- DRKS00005059
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-06-01
- Last update in DRKS:
- 2016-07-11
- Registration type:
- Retrospective
Acronym/abbreviation of the study
/
URL of the study
Brief summary in lay language
Due to possible negative effects of anesthetic agents on the developing brain, we intend to analyse wether infants need sedation medication in conjunktion with a regional anesthesia at all. Infants (0-3 months age), who have to undergo lower body surgery in caudal anaesthesia, will be included. Comfort B Scale will be used to evaluate the depth of sedation and if there is a anaesthetic drug necessary at all. Two groups will be included. Group1 no anaesthetic drug (exept if required), Group2 will get a continuous infusion of Propofol 5mg/kg KG. Aim of the study is the total need of propofol doses in both groups.
Brief summary in scientific language
Infants and children undergoing anorectal, inguinal and lower extremity surgery do get a so called caudal block as anesthetic procedure of choice. It is the most commonly performed regional anesthesia in children and infants. For this well investigated regional anaesthetic technique the patient will be turned into the left lateral position and 1 ml/kg BW Ropivacaine 0.2% or 0.35% will be injected into the caudal space under aseptic conditions. According to the departmental standard and depending on the practical knowledge of the anesthetist, there is a possibility to monitor the spread of the lokal anesthetic into the epidural space using an ultrasound to ensure the correct injection of the LA18. Even though many institutions perform this regional anesthetic procedure in conjunction with general anesthesia, it is unclear wether the patients need anesthetic agents additionally at all. Based on our clinical experience and the suggestion that there is a possibility that the resaborption of the local anesthetic through the epidural space contributes a main part of the sedation effect, we perform this kind of regional procedure only with a light sedation using propofol in a dosage 5mg/kg BW. However, recently published studies suggest a negative effect of anesthetic agents on the developing brain particularly in infants. We therefore designed a study in order to analyse the level of sedation wether if there is a necessity of Propofol or not.
Health condition or problem studied
- ICD10:
- K40.9 - Unilateral or unspecified inguinal hernia, without obstruction or gangrene
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Infants who will undergo lower body surgery in caudal anaesthesia, won't get a continuous infusion of propofol.
- Arm 2:
- Infants who will undergo lower body surgery in caudal anaesthesia, will get a continuous infusion of propofol in a dosage of 5mg/kg KG/h administered.
Endpoints
- Primary outcome:
- The main objective of the recent study is to investigate the need of additional anesthetic agents such as Propofol in children with caudal blockade undergoing lower body surgery. To evaluate the level of sedation we use the Comfort-B Skala19 ( a sedation score for children). The evaluation starts at skin incision by the surgery (every 10 minutes) until the transfer to the normal ward.
- Secondary outcome:
- /
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie Wien
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-10-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2015-10-07
- Target Sample Size:
- 34
- Final Sample Size:
- 34
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 0 Months
- Maximum Age:
- 3 Months
- Additional Inclusion Criteria:
- - Infants aged between 0 and 3 months - Lower body surgery with planned caudal blockade - Written informed consent given by parents after being provided with detailed information about the nature, risks, and scope of the clinical study
Exclusion Criteria
- Parents refusal - Contraindications against a caudal blockade - Coagulopathy
Addresses
Primary Sponsor
- Address:
- Anästhesie, Allgemeine Intensivmedizin und SchmerztherapieUniv.- Prof. Dr. Klaus MarkstallerWähringer Gürtel 18-201090 WienAustria
- Telephone:
- 00 43 1 40400 4100
- Fax:
- 00 43 1 40400 4028
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.meduniwien.ac.at
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- AKH WienDr.med.univ Wolfgang KlugWähringer Gürtel 18-201090 WienAustria
- Telephone:
- 0043 1 19231
- Fax:
- 0043 1 19256
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://meduniwien.ac.at
Contact for Public Queries
- Address:
- AKH WienDr.med.univ Wolfgang KlugWähringer Gürtel 18-201090 WienAustria
- Telephone:
- 0043 1 19231
- Fax:
- 0043 1 19256
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://meduniwien.ac.at
Principal Investigator
- Address:
- AKH WienDr.med.univ Wolfgang KlugWähringer Gürtel 18-201090 WienAustria
- Telephone:
- 0043 1 19231
- Fax:
- 0043 1 19256
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://meduniwien.ac.at
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Anästhesie, Allgemeine Intensivmedizin und SchmerztherapieWähringer Gürtel 18-201090 WienAustria
- Telephone:
- 00 43 1 40400 4100
- Fax:
- 00 43 1 40400 4028
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.meduniwien.ac.at
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Universität WienBorschkegasse 8b/E061090 WienGermany
- Telephone:
- (+43)1-40400-21470
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-09-03
- Ethics committee number:
- 1697/2013
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-09-24
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry