Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lithium Carbonate 250 MG
Calcium Carbonate 500 MG
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation focused on measuring bispectral index, lithium carbonate
Eligibility Criteria
Inclusion Criteria:
- • 1. ethnic Chinese;
- • 2. age, 18 to 75 years old;
- • 3. American Society of Anaesthesiologists (ASA) physical status I or II;
- • 4. required VATS for lung surgery and one lung ventilation
Exclusion Criteria:
- Cognitive difficulties
- • Partial or complete gastrectomy
- • Previous esophageal surgery
- • Previous treated by radiotherapy or surgery
- • Inability to conform to the study's requirements
- • body mass index exceeding 30 kg/m2
- • Deprivation of a right to decide by an administrative or juridical entity
- • Ongoing participation or participation in another study <1 month ago
- • preoperative Pittsburgh Sleep Quality Index global scores higher than 6
- • recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Sites / Locations
- the First Hospital of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
lithium carbonate
calcium carbonate
Arm Description
Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.
Outcomes
Primary Outcome Measures
sleep quality
The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04479566
First Posted
July 17, 2020
Last Updated
February 2, 2022
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT04479566
Brief Title
Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
Official Title
Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing video assisted thoracic surgery taken 250mg lithium carbonate 6 hours after surgery.
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
bispectral index, lithium carbonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lithium carbonate
Arm Type
Experimental
Arm Description
Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
Arm Title
calcium carbonate
Arm Type
Placebo Comparator
Arm Description
Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate 250 MG
Intervention Description
Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate 500 MG
Intervention Description
Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.
Primary Outcome Measure Information:
Title
sleep quality
Description
The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery
Time Frame
first postoperative night
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• 1. ethnic Chinese;
• 2. age, 18 to 75 years old;
• 3. American Society of Anaesthesiologists (ASA) physical status I or II;
• 4. required VATS for lung surgery and one lung ventilation
Exclusion Criteria:
Cognitive difficulties
• Partial or complete gastrectomy
• Previous esophageal surgery
• Previous treated by radiotherapy or surgery
• Inability to conform to the study's requirements
• body mass index exceeding 30 kg/m2
• Deprivation of a right to decide by an administrative or juridical entity
• Ongoing participation or participation in another study <1 month ago
• preoperative Pittsburgh Sleep Quality Index global scores higher than 6
• recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Facility Information:
Facility Name
the First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
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