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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479566
• Other study ID #: 2020-27-2
• Status: Completed
• Phase: Phase 4
• Start date: November 6, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2020
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Drug:
• Lithium Carbonate 250 MG
Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
• Calcium Carbonate 500 MG
Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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