Postoperative DeliriumNCT04193280
Blood Sugar Level and Postoperative Agitations in Pediatric Surgery
An observational study of Postoperative Delirium, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of fasting time and blood glucose levels on postoperative agitations in pediatric patients who will undergo outpatient surgery. Read more about this study
- Who is it for?
- Ages 18 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 30 Jun 2020
- 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 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will include children between 2-12 years of age who will be operated in the pediatric operating room. Circumcision, inguinal hernia, undescended testis, lymphadenopathy excision, cystoscopy, adenotonsillectomy cases will be included in the study.
Who may be able to join
- Pediatric patients between 2-12 years of age who will undergo outpatient surgery
Who cannot join
- ASA III-IV patients, patients with congenital malformation and developmental delays, or any neurological or cardiac diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul MU Goztepe Training and Research Hospital
Istanbul, 34730
ZEYNEP N ORHON, 02165664000, zeynepnurorhon@gmail.com
About this study
Official title: Does Blood Sugar Level Affect Postoperative Agitations in Outpatient Pediatric Surgery?
The aim of this study is to investigate the effect of fasting time and blood glucose levels on postoperative agitations in pediatric patients who will undergo outpatient surgery.
Read the detailed description
Emergence delirium is a very important clinic phenomenon, characterized by irritability and severe restlessness in children recovering from anesthesia; it may cause injury to the child recovering from anesthesia or to surgical site and may also lead to parents, who witness emergence delirium to question the quality of anesthesia. Postoperative agitaitons, has been noted with the newer, less soluble inhaled agents and emergence delirium has become a serious problem, taken care in postanesthesia care unit for anesthesiologists. Preoperative anxiety, premedication, anesthetic drugs, pain, type of surgery and emergence in a foreign environment are the factors which take part in the development of emergence delirium. Emotional and less social children, the children with anxious parents, children undergoing upper airway surgery are under risk. Detection of children at risk, the use of appropriate adjuvant drugs, strict control of postoperative pain, and accompanying parents to their children in the recovery room are currently the primary measures to prevent recovery agitation. Further studies are required to discover underlying causes and management of emergence delirium.
In this study pre-and postoperative blood glucose values, preoperative fasting times and hemodynamic values of 200 American Society of Anesthesiologists (ASA) physical status I-2 patients will be recorded. At the end of the operation, patients will be evaluated with Modified Aldrete Sedation Scale, FLACC Pain Rating Scale and PAED Agitation Scale. The results obtained will be evaluated with statistical methods and the relationship between preoperative fasting time and blood glucose levels and postoperative agitations will be investigated.
- Conditions
- Postoperative Delirium
- Keywords
- Preoperative fasting time,, Blood glucose level, Postoperative Delirium
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sugar level
Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.
Measured: 11.1.2019-5.31.2020
The fasting time
Fasting time will be recorded.
Measured: 11.1.2019-5.31.2020
The change in blood sugar level
According to the type of operation, the change in blood sugar level will be detected. Correlation of this change with postoperative agitation will be investigated
Measured: 11.1.2019-5.31.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Nov 2019
- Primary completion31 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Nur Orhon, Istanbul Medeniyet University
- Investigators
- Zeynep N Orhon, MD, Principal investigator, Istanbul Medeniyet University Goztepe Research and Traininig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193280
- Sponsor's protocol ID
- IstanbulMUPediatricAnesthesia
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Blood Sugar Level Affect Postoperative Agitations in Outpatient Pediatric Surgery?
- ClinicalTrials.gov ID
- NCT04193280
- Acronym / sponsor ID
- IstanbulMUPediatricAnesthesia
- Conditions
- Postoperative Delirium
- Keywords
- Preoperative fasting time,, Blood glucose level, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 10 Dec 2019 (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.
The aim of this study is to investigate the effect of fasting time and blood glucose levels on postoperative agitations in pediatric patients who will undergo outpatient surgery.
Detailed description
Emergence delirium is a very important clinic phenomenon, characterized by irritability and severe restlessness in children recovering from anesthesia; it may cause injury to the child recovering from anesthesia or to surgical site and may also lead to parents, who witness emergence delirium to question the quality of anesthesia. Postoperative agitaitons, has been noted with the newer, less soluble inhaled agents and emergence delirium has become a serious problem, taken care in postanesthesia care unit for anesthesiologists. Preoperative anxiety, premedication, anesthetic drugs, pain, type of surgery and emergence in a foreign environment are the factors which take part in the development of emergence delirium. Emotional and less social children, the children with anxious parents, children undergoing upper airway surgery are under risk. Detection of children at risk, the use of appropriate adjuvant drugs, strict control of postoperative pain, and accompanying parents to their children in the recovery room are currently the primary measures to prevent recovery agitation. Further studies are required to discover underlying causes and management of emergence delirium.
In this study pre-and postoperative blood glucose values, preoperative fasting times and hemodynamic values of 200 American Society of Anesthesiologists (ASA) physical status I-2 patients will be recorded. At the end of the operation, patients will be evaluated with Modified Aldrete Sedation Scale, FLACC Pain Rating Scale and PAED Agitation Scale. The results obtained will be evaluated with statistical methods and the relationship between preoperative fasting time and blood glucose levels and postoperative agitations will be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will include children between 2-12 years of age who will be operated in the pediatric operating room. Circumcision, inguinal hernia, undescended testis, lymphadenopathy excision, cystoscopy, adenotonsillectomy cases will be included in the study.
Key inclusion criteria (1 listed)
- Pediatric patients between 2-12 years of age who will undergo outpatient surgery
Key exclusion criteria (1 listed)
- ASA III-IV patients, patients with congenital malformation and developmental delays, or any neurological or cardiac diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood sugar level
Time frame: 11.1.2019-5.31.2020
Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.
The fasting time
Time frame: 11.1.2019-5.31.2020
Fasting time will be recorded.
The change in blood sugar level
Time frame: 11.1.2019-5.31.2020
According to the type of operation, the change in blood sugar level will be detected. Correlation of this change with postoperative agitation will be investigated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Zeynep N Orhon, MD principal investigator
Istanbul Medeniyet University Goztepe Research and Traininig Hospital
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 Postoperative Delirium, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 10 Dec 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynep N Orhon, MD (02165664000, zeynepnurorhon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sugar level (time frame: 11.1.2019-5.31.2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2019.