The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study

NCT02325648 | Completed

• 1 other identifier: 4-2014-0854
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. It is widely known that HIPEC entails severe physiological changes and precautions during anesthesia. However, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. Therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. The investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC cytoreductive surgeries.

Conditions

Peritoneal Surface Malignancies

Outcome Measures

Primary Outcomes (4)

• Vital sign

  from 30 minutes to 90 minutes after HIPEC

• Body temperature

  from 30 minutes to 90 minutes after HIPEC

• serum glucose

  from 30 minutes to 90 minutes after HIPEC

• pulmonary vascular permeability index

  from 30 minutes to 90 minutes after HIPEC

Study Arms (1)

HIPEC cytoreductive surgery

Drug: HIPEC cytoreductive surgery

Interventions

HIPEC cytoreductive surgery DRUG

At least 30 minutes prior to the prospective conclusion of the surgery, 1 μg/kg of fentanyl is administered for postoperative analgesia and 0.075mg of palonosetron is IV-infused for the prevention of nausea and vomiting. Desflurane and remifentanil administration is ceased after the surgery is concluded, muscle relaxation is evaluated by train of four (TOP) monitoring using a nerve stimulator, and the neuromuscular blockade is reversed with 0.2 mg of glycopyrrolate and 1 mg of neostigmine. When the patient recovers consciousness and begins spontaneous respiration, extubation is performed and the patient is transferred to the ICU with monitoring of their vital signs.

HIPEC cytoreductive surgery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who undergoing HIPEC cytoreductive surgery

You may qualify if:

• Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital

You may not qualify if:

• Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea, 120-752, South Korea

Location

Related Publications (1)

• Kim MH, Yoo YC, Bai SJ, Lee KY, Kim N, Lee KY. Physiologic and hemodynamic changes in patients undergoing open abdominal cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. J Int Med Res. 2021 Jan;49(1):300060520983263. doi: 10.1177/0300060520983263.

  PMID: 33445991 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2014
• First Posted: December 25, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

KR (1)