Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Active Prewarming in Perioperative Hypothermia in Adults

NCT04033900

Hypothermia; Anesthesia Hypothermia Due to Anesthetic Hypothermia Following Anesthesia +1 more

COMPLETED NA

Impact of Forced Air Warming on Perioperative Thermodynamics

NCT03191214

Hypothermia Following Anesthesia

UNKNOWN

Perioperative Normothermia: Temperature and Prewarming Methods

NCT04011462

Hypothermia

UNKNOWN NA

Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia

NCT04027842

Hypothermia; Anesthesia

COMPLETED NA

Impact of Expanded Peri Operative Warming

NCT01649596

Hypothermia Complications

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypothermia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard

Study arm in which patients are treated according to standard operating procedures. Acting as "control arm".

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard + Microdialysis

Study arm in which patients are treated according to standard operating procedures but also receive Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue.

Group Type EXPERIMENTAL

Microdialysis

Intervention Type DEVICE

71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden

Prewarm

Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.

Group Type EXPERIMENTAL

Prewarming

Intervention Type OTHER

Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.

Prewarm + Microdialysis

Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia and Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue

Group Type EXPERIMENTAL

Prewarming

Intervention Type OTHER

Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.

Microdialysis

Intervention Type DEVICE

71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prewarming

Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.

Intervention Type OTHER

Microdialysis

71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \> 18
* elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary

Exclusion Criteria

* age \< 18
* refusal participate in study
* pregnant or breast-feeding women
* cardiac ejection fraction \< 30%
* terminal renal insufficiency requiring dialysis
* severe pulmonary disease (Gina-Classification\< 3)
* neurological and/or psychiatric disease
* patient is placed in an institution due to court order
* lack of language skills/understanding
* employee of Charité Berlin
* alcohol addiction
* refusal of epidural anesthesia or failure to insert epidural catheter
* participation in other perioperative, invasive studies which prohibit further study inclusion

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No