Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial
Introduction Postoperative delirium (POD) is prevalent in patients after major surgery and is associated with adverse outcomes. Several studies have reported that dexmedetomidine, a highly selective α2-adrenergic receptor agonist, can decrease the incidence of POD. However, neurosurgical patients ar...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-11-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e040939.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846157195297685504 |
|---|---|
| author | Hongqiu Gu Linlin Zhang Jian-Xin Zhou Xuan He Kun-Ming Cheng Xin Qu Yuan Xu Penglin Ma |
| author_facet | Hongqiu Gu Linlin Zhang Jian-Xin Zhou Xuan He Kun-Ming Cheng Xin Qu Yuan Xu Penglin Ma |
| author_sort | Hongqiu Gu |
| collection | DOAJ |
| description | Introduction Postoperative delirium (POD) is prevalent in patients after major surgery and is associated with adverse outcomes. Several studies have reported that dexmedetomidine, a highly selective α2-adrenergic receptor agonist, can decrease the incidence of POD. However, neurosurgical patients are usually excluded from previous studies. The present study was designed to investigate the impact of prophylactic use of low-dose dexmedetomidine on the incidence of POD in patients after intracranial operation.Methods and analysis This is a multicentre, randomised, double-blinded and placebo-controlled trial. Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio. For patients in the dexmedetomidine group, a continuous infusion of dexmedetomidine will be started at a rate of 0.1 μg/kg/hour immediately after enrolment on the day of operation and continued until 08:00 on postoperative day 1. For patients in the placebo group, normal saline will be administered at the same rate as in the dexmedetomidine group. The patients will be followed up for 28 days after enrolment. The primary endpoint is the incidence of POD, which is assessed two times per day using the Confusion Assessment Method for the intensive care unit (ICU), during the first 5 postoperative days. The secondary endpoints include the incidence of dexmedetomidine-related adverse events and non-delirium complications, the length of stay in the ICU and hospital and all-cause 28-day mortality after the operation.Ethics and dissemination The study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (No KY2019-091-02) and registered at ClinicalTrials.gov. The results of the trial will be presented at national and international conferences relevant to subject fields and submitted to international peer-reviewed journals.Trial registration number Trial registration number: NCT04399343; Pre-results. |
| format | Article |
| id | doaj-art-cfeabfb6513f4b3691d0f1594c657865 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-cfeabfb6513f4b3691d0f1594c6578652024-11-25T13:05:08ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-040939Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trialHongqiu Gu0Linlin Zhang1Jian-Xin Zhou2Xuan He3Kun-Ming Cheng4Xin Qu5Yuan Xu6Penglin Ma71 China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Rehabilitation Medicine, Nantong Fourth People`s Hospital, Nantong, Jiangsu, China15 Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China7 Beijing Tiantan Hospital, Capital Medical University, Beijing, China1 Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, ChinaMinistry of Health and Medical Services, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College Hospital, Beijing, China5 Department of Critical Care Medicine, Peking University Third Hospital, Beijing, ChinaIntroduction Postoperative delirium (POD) is prevalent in patients after major surgery and is associated with adverse outcomes. Several studies have reported that dexmedetomidine, a highly selective α2-adrenergic receptor agonist, can decrease the incidence of POD. However, neurosurgical patients are usually excluded from previous studies. The present study was designed to investigate the impact of prophylactic use of low-dose dexmedetomidine on the incidence of POD in patients after intracranial operation.Methods and analysis This is a multicentre, randomised, double-blinded and placebo-controlled trial. Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio. For patients in the dexmedetomidine group, a continuous infusion of dexmedetomidine will be started at a rate of 0.1 μg/kg/hour immediately after enrolment on the day of operation and continued until 08:00 on postoperative day 1. For patients in the placebo group, normal saline will be administered at the same rate as in the dexmedetomidine group. The patients will be followed up for 28 days after enrolment. The primary endpoint is the incidence of POD, which is assessed two times per day using the Confusion Assessment Method for the intensive care unit (ICU), during the first 5 postoperative days. The secondary endpoints include the incidence of dexmedetomidine-related adverse events and non-delirium complications, the length of stay in the ICU and hospital and all-cause 28-day mortality after the operation.Ethics and dissemination The study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (No KY2019-091-02) and registered at ClinicalTrials.gov. The results of the trial will be presented at national and international conferences relevant to subject fields and submitted to international peer-reviewed journals.Trial registration number Trial registration number: NCT04399343; Pre-results.https://bmjopen.bmj.com/content/10/11/e040939.full |
| spellingShingle | Hongqiu Gu Linlin Zhang Jian-Xin Zhou Xuan He Kun-Ming Cheng Xin Qu Yuan Xu Penglin Ma Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial BMJ Open |
| title | Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial |
| title_full | Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial |
| title_fullStr | Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial |
| title_full_unstemmed | Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial |
| title_short | Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial |
| title_sort | dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours depod study a study protocol and statistical plan for a multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/11/e040939.full |
| work_keys_str_mv | AT hongqiugu dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial AT linlinzhang dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial AT jianxinzhou dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial AT xuanhe dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial AT kunmingcheng dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial AT xinqu dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial AT yuanxu dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial AT penglinma dexmedetomidineforthepreventionofpostoperativedeliriuminpatientsafterintracranialoperationforbraintumoursdepodstudyastudyprotocolandstatisticalplanforamulticentrerandomisedcontrolledtrial |