Does preoperative heating of patients undergoing elective orthopedic surgery reduce the incidence of intraoperative hypothermia and postoperative comfort and modulate postoperative glucose and insulin blood levels?
ID
Source
Brief title
Condition
- Other condition
- Bone and joint therapeutic procedures
Synonym
Health condition
Perioperatief bloedverlies en postoperatieve hyperglycemie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of perioperative hypothermia
Secondary outcome
Perioperative blood loss
Patient discomfort as defined by pain, nausea and vomiting, shivering and
thermal discomfort
Postoperative glucose and insulin levels
Background summary
Hypothermia, defined as a core temperature below 36 degrees Celcius, is
commonly seen in patients undergoing surgery. Intraoperative hypothermia is
related to postoperative patient discomfort, impaired wound healing, increased
blood loss, anxiety and disturbances in glucose and insulin levels. Prewarming
of patients prior to surgery may result in maintenance of intraoperative
temperature and reduce postoperative complications. We therefore aim to
investigate the effects of prewarming of patients undergoing elective
orthopedic surgery on intraoperative temperature control and blood loss and
postoperative patient discomfort and glucose and insulin levels.
Study objective
Does preoperative heating of patients undergoing elective orthopedic surgery
reduce the incidence of intraoperative hypothermia and postoperative comfort
and modulate postoperative glucose and insulin blood levels?
Study design
Multi-center, prospective, randomized clinical trial.
Study burden and risks
All measurement parameters are part of standard perioperative and clinical
care, except for drawing of ablood samples for the determination of glucose,
insulin, Hb, Ht, creatinine kinase, lactate, APTT and INR (in total 76 ml)
There are three modalities that will be applied to draw patient blood:
1) Blood sampling from an intravenous catheter. Peripheral intravenous catheter
placement is standard perioperative procedure in all surgical patients, and
will therefore not add up to patient discomfort in the present study.
2) Blood sampling by intravenous puncture. There is a 10-20% chance that blood
sampling can not sufficiently be performed through an intravenous catheter. In
this case, blood sampling will be performed by an intravenous puncture. Blood
sampling will be performed on three different time-points, two during
anesthesia and one at the postoperative ward. On the postoperative ward
patients are recovering from anesthesia and patient discomfort due to blood
sampling will be the highest in this particular population.
3) Glucose levels using a glucose meter device. Postoperative serum glucose
levels can be measured using a glucose meter device. A single puncture in the
index finger the obtain blood will be necessary and this will be minimal
invasive.
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
Patients undergoing an elective orthopedic knee- or hip replacement
Participation based on informed consent
> 18 years old and < 85 years old
Exclusion criteria
BMI 18.5 > x < 40
Pregnancy
Non elective trauma patients
Infectious or febrile patients (> 37.5oC)
Diabetes Mellitus
Combined surgery
Anemia (Hb < 4.0 mmol/l)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17356.029.07 |