Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Cognition Disorders

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

A loading dose of dexmedetomidine (0.5 ug/kg IV infusion in 15 minutes) will be administered after induction of general anesthesia, followed by continuous infusion at a rate of 0.5 ug/kg/h until the closure of the duramater of the brain.

Normal saline will be administered in the same rate and volume as that in the dexmedetomidine group.

A loading dose dexmedetomidine (0.5 ug/kg IV infused in 15 minutes) will be administered after anesthesia induction, followed by a continuous infusion at a rate of 0.5 ug/kg/h until the closure of the brain duramater at the end of surgery.

dexmedetomidine

Normal saline will be administered in the same rate, volume and duration as that in the dexmedetomidine group

normal saline

Dong-Xin Wang, MD, PhD

The purpose of this randomized, double-blind and placebo-controlled pilot study is to investigate whether dexmedetomidine when used as an adjuvant to general anesthesia can decrease the harmful effects of anesthesia and surgery on intelligence development in pediatric patients undergoing craniotomy.

General anesthetics and sedatives are administered to millions of children each year to facilitate life-saving surgery and other essential surgical or medical procedures. In the past two decades, mounting evidence from animal and clinical studies have raised concerns that general anesthetics may produce harmful effects in the developing brain and lead to adverse neurodevelopmental outcomes. Factors that may influence the degree of injury include age at the time of drug exposure/surgery and cumulative anesthetic dose.

The Intelligence Quotients of pediatric patients with intracranial tumors are lower when compared with healthy children of same age. The investigators suppose that these patients are more sensitive to the neurotoxic effects of general anesthetics. Dexmedetomidine is an alpha 2-adrenoceptor agonist that provides sedation, anxiolysis, and analgesia, and has been shown to be safe to the brain in animal studies. In clinical studies, the use of dexmedetomidine decreases the consumption of anesthetics and opioids during general anesthesia and suppresses stress response induced by surgery. The investigators hypothesize that dexmedetomidine, when used as an adjuvant to general anesthesia, can reduce the neurotoxic effects of general anesthetics by decreasing anesthetic consumption and inhibiting stress response.

The purpose of this randomized, double-blind and placebo-controlled pilot study is to investigate whether dexmedetomidine, when used as an adjuvant to general anesthesia, can decrease the harmful effects of anesthesia and surgery on intelligence development of pediatric patients undergoing craniotomy.

Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy

The Effect of Dexmedetomidine as an Adjuvant to General Anesthesia on Intelligence Development in Pediatric Patients Undergoing Craniotomy: a Randomized, Double-blind and Placebo-controlled Pilot Trial

Tested with Chinese Binet Intelligence Scale

Agitation will be assessed with anesthesia emergence agitation score.

Beijing Tiantan Hospital

Peking University First Hospital

Professor

Wounds and Injuries

Symptoms and General Pathology

Neoplasm Metastasis

Rupture

Lacerations

Neoplastic Processes

100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process

100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing

100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management

A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation.

Clinical examination and pictures

The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems.

Questionnaire

Lærke V. Moestrup, PhD student

Hanna M. Jangö, MD, PhD

Hanna M. Jangö, MD, PhD, Associate Professor

Lærke V. Moestrup, Midwife, MSc, PhD-student

Thomas Bergholt, Prof., Chief Physician, PhD

Hanne K. Hegaard, Prof., Midwife, PhD

Niels Klarskov, Prof., Chef Physician, DMSc

The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a healing process with a dehisced wound treated with conservative management or secondary suturing.

Participants will be asked to do

* A gynecological examination at one month after birth and 9-12 months after birth.
* Have a picture taken of the healing process
* Answer a questionnaire at one month, three months, and 9-12 months after birth

The best way to manage perineal wound dehiscence after childbirth is unknown. Currently, there is no agreed best practice recommendation for managing perineal wound dehiscence due to a lack of evidence comparing conservative management with secondary suturing. Therefore, studies are urgently needed to compare the benefits and risks of both treatments. This study has the potential to significantly impact women´s health for those suffering from perineal wound dehiscence.

The investigators want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with a normal/uncomplicated healing process, 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with secondary resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with conservative management.

All women who meet the inclusion criteria are recommended the same treatment and follow-up as currently present as standard care at the four hospitals that the investigators are recruiting from. The study deviates from the standard of care by offering two extra clinical examinations, one questionnaire evaluation without clinical examination, and a follow-up with pictures of the perineal tear healing process.

Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour

Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing

Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale

The proportion of women with healed wounds at one month post-partum assessed by clinical examination and REEDA scale (Redness, Oedema, Ecchymosis, Discharge, Approximation of the wound edges). The REEDA scale contains five criteria each receiving a score between 0 and 3. The total score range from 0 - 15 with lower scores representing better-wound healing

The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale

Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound

The woman will be asked whether she is breastfeeding or not

The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p.

Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)

Measured by the ICIQ-UI SF questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)

Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B)

Measured by Edinburgh Postnatal Depression Scale (EPDS). EPDS is a self-assessment questionnaire consisting of ten statements and the respondent is asked about their feelings over the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Denmark, women are said to have depressive symptoms after delivery if they score 11 or higher

Self-reported pain intensity measured by Visual Analog Scale (VAS-score). Numeric rating scale from 0-10 (0 = no pain - 10 = pain as bad as can be)

The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy	NCT02810899	Brain Neoplasms	dexmedetomidine normal saline	2 Years - 12 Years	Peking University First Hospital
Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour	NCT06026423	Dehiscence Woun... Secondary Perin... Episiotomy; Deh...	Clinical examin... Questionnaire	18 Years -	Herlev Hospital
Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour	NCT06026423	Dehiscence Woun... Secondary Perin... Episiotomy; Deh...	Clinical examin... Questionnaire	18 Years -	Herlev Hospital
Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy	NCT02810899	Brain Neoplasms	dexmedetomidine normal saline	2 Years - 12 Years	Peking University First Hospital

Spots Global Cancer Trial Database for dehiscence

Every month we try and update this database with for dehiscence cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dehiscence

Every month we try and update this database with for dehiscence cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dehiscence cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.