Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2025-12-17 @ 12:12 PM
Study NCT ID:
NCT04479566
Status:
None
Last Update Posted:
2022-02-04 00:00:00
First Post:
2020-07-17 00:00:00
Brief Title:
Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
Sponsor:
China Medical University China
Organization:
China Medical University, China
Study Overview
Official Title:
Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
Status:
None
Status Verified Date:
2020-11
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:
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing video assisted thoracic surgery during morning will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) 6 hours after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the first postoperative night sleep quality. The patients received standardized general anesthesia supplemented by paravertebral nerve block. The ultrasound-guided approach for paravertebral nerve block was used with the patient in the lateral decubitus position, and the paravertebral nerve block was administered at the T4-T6 level according to the incision protocol at our center. General anesthesia for maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min, Renfu, Yichang, China) was given to all patients during the operation. All patients accepted patient-controlled intravenous analgesia with 1 μg ml-1 sufentanil (Renfu, Yichang, China). Duration of sleep was defined as the duration of all bispectral index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).
Detailed Description:
This study is a prospective randomized controlled randomized parallel group concealed allocation double-blinded trial All patients undergoing video assisted thoracic surgery during morning will be randomized 11 to the treatment intervention with lithium carbonate 250mg Baoqing Hunan China or calcium carbonate 500mg Reneed Beijing China 6 hours after surgery The objective of the trial is to evaluate the lithium carbonate 250mg on the first postoperative night sleep quality The patients received standardized general anesthesia supplemented by paravertebral nerve block The ultrasound-guided approach for paravertebral nerve block was used with the patient in the lateral decubitus position and the paravertebral nerve block was administered at the T4-T6 level according to the incision protocol at our center General anesthesia for maintenance of propofol anesthesia total intravenous anesthesia was administered by using propofol Fresenius Kabi Austria GmbH at a plasma target concentration Marsh pharmacokinetic model software of 25-4 μgml Remifentanil 02-05 μgkgmin Renfu Yichang China was given to all patients during the operation All patients accepted patient-controlled intravenous analgesia with 1 μg ml-1 sufentanil Renfu Yichang China Duration of sleep was defined as the duration of all bispectral index data below 80 in the 12 hours of monitoring from 2000pm to 0600am
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None