Preoperative Administration of Oral Carbohydrate Drink and Postoperative Insulin Resistance

NCT ID: NCT03793036

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-12-31

Brief Summary

This study compared traditional concept of preoperative fasting before elective open colon surgery and preoperative treatment with carbohydrate oral drink in intention to improve postoperative stress response to surgical procedure. Hypothesis was: preoperative oral carbohydrate drink reduces postoperative insulin resistance, improves insulin sensitivity, reduces postoperative inflammatory response in terms of the value of Glasgow Prognostic Score (GPS) and IL-6, improves postoperative patient's subjective well-being and surgical clinical outcome.

Detailed Description

This prospective randomized, controlled clinical study was carried out in the Department of Anesthesiology and Intensive Care Unit and Department of Surgery at the Cantonal Hospital Zenica, Bosnia and Herzegovina. After obtaining ethical committee approval 50 participants, scheduled for elective open colon surgery were included into study. Sample size was estimated using sample size calculator software and power analysis with 95% confidence interval and power of 80%. Statistical significance was considered as p< 0,05. The calculation indicated 19 participants per group would be sufficient to detect a 50% difference for insulin resistance between the groups. Assuming dropout would lead to a total sample size of 50 participants. Before each participant agreed to the join the study, the purpose and procedures of the study were fully explained and informed and written consent was obtained from each participant. A preoperative anesthetic examination was conducted the day before surgery. The participants who fulfilled study criteria were randomly allocated into two groups of 25 participants, depending on the preoperative treatment. The intervention group, received preoperative carbohydrate oral supplementation (CHO group) and the control group (FAST group) underwent to a conventional routine of preoperative fasting. Randomization was performed by computer generated randomization codes. The codes which indicated the treatment were held in sealed opaque envelopes. Nurse who conducted randomization and opened the envelopes the night before surgery was blinded to the study protocol as well as the surgeons, nurses, anesthesiologists and staff involved in data collection.

The participants of FAST group were undergone to the traditional concept of preoperative fasting before surgical procedure. The participants in the intervention group received carbohydrate oral supplement at 10:00 pm the evening before surgery and again on the day of surgery, 2 hours before induction of anesthesia. Assessment of clinical parameters started at 06:00 am on the day of surgery (basal value). The fasting peripheral venous blood samples were collected to measure serum levels of glucose, insulin, C-reactive protein, albumin and IL-6, and further 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. All patients underwent general anesthesia followed by colon surgery. Assessment of subjective well-being was performed immediately before induction into anesthesia using a 10 cm horizontal Visual Analogue Scales and then repeated for 0-4, 4-8, 8-12 and 12-24 hours post-surgery. Pain at rest, pain with mobilization, thirst, hunger, mouth dryness, anxiety and weakness were evaluated. The patients were explained how to use the scale. Surgical outcome was evaluated by postoperative return of gastrointestinal function, time to independent ambulation and postoperative discharge day. Postoperative data included and the time to oral intake. The following data were recorded also: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA) physical status class, nutritional status of the participants according to Nutritional Risk Screening 2002 (NRS-2002), tumor localization, type of surgery, duration of surgery, preoperative fasting time and, blood loss during surgery

Conditions

Insulin Resistance; Inflammatory Response; Exaggerated Well-Being; Length of Stay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

FAST group

preoperative fasting

Group Type: NO_INTERVENTION

No interventions assigned to this group

CHO group

preoperative nutrition The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

Group Type: EXPERIMENTAL

preoperative nutrition

Intervention Type: DIETARY_SUPPLEMENT

The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

Interventions

preoperative nutrition

The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• participants with ASA physical status class I-II
• aged between 18 years and 70 years
• participants scheduled for elective open colon surgery

Exclusion Criteria

• previous treatment of colon or any other cancer
• disseminated malignant disease
• gastro-oesophageal reflux or increased risk of aspiration
• body mass index below 20 and above 30 kg/m2
• overall score ≥3 after final assessment of the nutritional status according to Nutritional Risk Screening 2002 (NRS-2002)
• emergency colon surgery
• diabetes mellitus
• inflammatory bowel disease
• immunological therapy
• cardiopulmonary disease
• neuromusular disease
• renal disease
• hepatic or endocrine disease
• pregnancy
• mental disease
• allergy to any study drugs
• alcoholic or drug abuse
• patient's refusal to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nermina Rizvanović

OTHER

Sponsor Role: lead

Responsible Party

Nermina Rizvanović

MD Anesthesiology and Intensive Care Specialist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nermina Rizvanović, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Zenica, Crkvice 67, 72 000 Zenica, Bosnia and Herzegovina

Locations

Cantonal Hospital Zenica

Zenica, , Bosnia and Herzegovina

Countries

Bosnia and Herzegovina

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Other Identifiers

NR01/19

Identifier Type: -

Identifier Source: org_study_id