NCT04479566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 4, 2022

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

July 17, 2020

Last Update Submit

February 2, 2022

Conditions

Sleep Deprivation

Keywords

bispectral indexlithium carbonate

Outcome Measures

Primary Outcomes (1)

  • 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

    first postoperative night

Study Arms (2)

lithium carbonate

EXPERIMENTAL

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

Drug: Lithium Carbonate 250 MG

calcium carbonate

PLACEBO COMPARATOR

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

Drug: Calcium Carbonate 500 MG

Interventions

Lithium Carbonate 250 MGDRUG

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

lithium carbonate
Calcium Carbonate 500 MGDRUG

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

calcium carbonate

Eligibility Criteria

Age18 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Lithium CarbonateCalcium Carbonate

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium CompoundsCalcium CompoundsMinerals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 21, 2020

Study Start

November 6, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 4, 2022

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)