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Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery

Sponsor
China Medical University, China (Other)
Overall Status
Completed
CT.gov ID
NCT04479566
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
14.8
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lithium Carbonate 250 MG
  • Drug: Calcium Carbonate 500 MG
 Phase 4

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
Actual Study Start Date :
Nov 6, 2020
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: lithium carbonate

Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.

Drug: Lithium Carbonate 250 MG
Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
Placebo Comparator: calcium carbonate

Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.

Drug: Calcium Carbonate 500 MG
Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.

Outcome Measures

Primary Outcome Measures

  1. sleep quality [first postoperative night]

    The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 the First Hospital of China Medical University Shenyang Liaoning China 110001

Sponsors and Collaborators

  • China Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wen-fei Tan, Professor, China Medical University, China
ClinicalTrials.gov Identifier:
NCT04479566
Other Study ID Numbers:
  • 2020-27-2
First Posted:
Jul 21, 2020
Last Update Posted:
Feb 4, 2022
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wen-fei Tan, Professor, China Medical University, China
bispectral index
lithium carbonate
Additional relevant MeSH terms:
Sleep Deprivation
Lithium Carbonate
Calcium Carbonate
Calcium

Study Results

No Results Posted as of Feb 4, 2022