Propofol EC50 for Inducing Loss of Consciousness in General Combined Epidural Anesthesia

NCT05124704 | Completed Results DMC

• 1 other identifier: IRB-2021-214
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The beneficial of perioperative usage of thoracic epidural anesthesia and analgesia in various thoracic and upper abdominal surgery are well studied. However, intraoperative data are lacking whether combined thoracic epidural and general anesthesia have effect on the median (50%) effective effect-concentration (EC50) of propofol for inducing loss of consciousness (LOC). We performed this study among patients undergoing open gastrectomy in gastric cancer patients. Sixty patients undergoing open gastrectomy were randomly assigned to two groups with thoracic combined general anesthesia (TEA+GA) or general anesthesia (GA) alone. Target-controlled infusion (TCI) of propofol was used for anesthesia induction. The initial propofol concentration of target effect-site (Ceprop) was 3.5 ug/ml and was increased stepwise by 0.5ug/ml at each 4 min intervals by an un-down sequential method to reach LOC. The predicted Ceprop at the time of LOC, intravenous anesthetics, vasopressor requirement, emergency time from anesthesia and postoperative numeric rating scale (NRS) were recorded and analyzed between two groups.

Conditions

Gastric Cancer

Keywords

Propofol EC50; Epidural anesthesia; Gastric cancer; Gastrectomy

Outcome Measures

Primary Outcomes (2)

• Propofol EC50 for Inducing Loss of Conciousness

  Recording propofol EC50 for inducing loss of conciousness between general with epidural anesthesia group and general group with propofol effect-site target-controlled infusion (TCI) system

  From anesthesia induction to patient loss of consciousness, an average of 5 minutes.

• Predicted Effect-site Concentration of Propofol (Ceprop) at Certain Time Points

  Recording the effect-site concentration of propofol (Ceprop) which showed on target-controlled infusion (TCI) system at loss of consciousness and discontinuation of anesthetics

  From anesthesia induction to the patient loss of consciousness, an average of 5 minutes.

Secondary Outcomes (2)

• Anesthetics Consumption

  From anesthesia induction to the end of surgery, an average of 2.5 hours.

• Postoperative Exhaust Time

  0-14 days postoperatively

Study Arms (2)

Combined epidural with general anesthesia

EXPERIMENTAL

Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.

Drug: 5-8ml 0.375% ropivacaine

General anesthesia

SHAM COMPARATOR

In this group, same dose of normal saline was administered before induction and during surgery.

Other: 5-8ml normal saline

Interventions

5-8ml 0.375% ropivacaine DRUG

5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction in experimental group. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.

Also known as: Experimental

Combined epidural with general anesthesia

5-8ml normal saline OTHER

5-8ml of normal saline depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.

Also known as: Sham control

General anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastric cancer patients age between 18-75 yrs;
• ASA physical state I and II
• Undergoing open gastrectomy

You may not qualify if:

• With contraindications to epidural puncture or catheter placement
• Chronic or acute (within 48 h) intake of psychotropic drugs, benzodiazepines, anticonvulsants, or opioids; alcoholism
• Hepatic, renal, neurological or other organ dysfunctiony
• Younger than 18 years or older than 75 years
• Allergic to local anesthetic solutions or opioids
• Received neo-adjuvant chemotherapy
• Refuse to receive epidural puncture

Sponsors & Collaborators

• Wang Jiangling: lead

Study Sites (1)

Cancer Hospital of the University of Chinese Academy of Sciences

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Wang J, Shen Y, Guo W, Zhang W, Cui X, Cai S, Chen X. Propofol EC50 for inducing loss of consciousness in patients under combined epidural-general anesthesia or general anesthesia alone: a randomized double-blind study. Front Med (Lausanne). 2023 Nov 6;10:1194077. doi: 10.3389/fmed.2023.1194077. eCollection 2023.

  PMID: 38020175 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Jiangling Wang
• Organization: Zhejiang Cancer Hospital

wangjl@zjcc.org.cn

15168373331

Study Officials

• Jiangling Wang, M.D

  Cancer Hospital of The University of Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Epidural puncture was performed by the fist anesthesiologist. First dosage and continuous infusion of ropivacaine was administered by the second anesthesiologist.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Resident

Model Details: 60 adult gastric cancer patients between 18-75 years, ASA physical state I and II, undergoing open gastrectomy, were enrolled in this study. Epidural puncture was performed in the left lateral position through the interspace between the eighth to ninth thoracic vertebra (T8-T9). Epidural catheter was inserted. In group TEA+GA, 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction, to obtain a bilateral segmentary sensory block to pinprick between T4 and T12 dermatomes. Continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction. In group GA, same dose of normal saline was administered before induction and during surgery.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 18, 2021
• Study Start: November 20, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)