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

February 2, 2022 updated by: Wen-fei Tan, China Medical University, China
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: 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
first postoperative night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2020

Primary Completion (ACTUAL)

January 31, 2022

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (ACTUAL)

July 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-27-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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