The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy

Sponsor
Ege University (Other)
Overall Status
Completed
CT.gov ID
NCT03131258
Collaborator
(none)
48
1
19

Study Details

Study Description

Brief Summary

Kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney transplantations are implemented with living donors.

Donor nephrectomy is an operations which has the end goal of a living donor donating one of his kidneys to a patient with end-stage kidney failure (1).

Pre-operative anxiety is a condition which is characterized by a random illness, being hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is to be experienced. Educating and informing in the pre-operative period is the first step in mentally preparing the patient for the operation. In some studies, it has been pointed out that patients who were thoroughly informed in the pre-operative period have lower anxiety levels both in the pre-operative and post-operative periods with also less levels of pain and increased recovery rates in the latter (2).

Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle strength.

Post-operative pain is acute pain which starts with surgical trauma and ends with tissue healing (3). Providing optimal post-operative analgesia plays an important role in the prevention of post-operative complications (1,4,5).

There are studies which examine the link between pre-operative anxiety and post-operative pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific group of patients both because they are not operated due to a health problem that they have and because the operation results with them losing an organ. There are no prospective studies about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in individuals who have undergone donor nephrectomy in literature. Because of this, we have aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in patients that were to undergo donor nephrectomy surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Donor Nephrectomy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Donor Nephrectomy

Donor Nephrectomy

Procedure: Donor Nephrectomy
48 Donor Nephrectomy Patients

Outcome Measures

Primary Outcome Measures

  1. Postoperative Pain Intensity [48 hours]

    Patient's pain intensity as measured by visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA I-II between 18-60 years

  • Donor Nephrectomy patients

Exclusion Criteria:
  • psychiatric disturbance

  • medicinal allergy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ege University

Investigators

  • Principal Investigator: Erbil Türksal, MD, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ERBIL TURKSAL, MD, Ege University
ClinicalTrials.gov Identifier:
NCT03131258
Other Study ID Numbers:
  • 14-5.1/5
First Posted:
Apr 27, 2017
Last Update Posted:
Apr 27, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2017