The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting

NCT04030884 | Completed DMC

• 1 other identifier: 03/05/2017-166977
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative nausea and vomiting (PONV) remains current as a complication and moderate evidence is available regarding the impact of preoperative oral carbohydrate-fluid administration on PONV. Honey, a natural source of carbohydrates, has an antioxidative effect and protects the gastric mucosa. Aim: To investigate the effect of oral honey and water for up to 2 hours preoperatively on PONV. Methods: A total of 142 elective thyroidectomy (experiment:35; control:37) and laparoscopic cholecystectomy (experiment:33; control: 37) patients were included. The experiment group was administered a 60 grams honey and 100 ml water mixture up to 2 hours preoperatively. The patients were monitored postoperative 0-6 hours using Rhodes Index of Nausea-Vomiting-Retching (R-INVR) and visual analog scale (VAS) for PONV.

Conditions

Postoperative Nausea and Vomiting

Keywords

postoperative nausea and vomiting; nursing; oral carbohydrate; honey

Outcome Measures

Primary Outcomes (6)

• PONV Occurence in all Participants by Rhodes Index of Nausea, Vomiting and Retching(R-INVR) Scores (8 items; each 0-4 points;total of 0-32 points)

  PONV measure; Any score above zero (\>0) indicates that participant experienced nausea. Each response is scored as 0: minimum, 4: maximum disturbance, and the score from 8 items was summed. The worst PONV experience can be expressed with the highest value of 32 points. 3 subscales were "experience, occurence, and distress". Experience (total experience score; 32): Nausea Experience Questions: 4,5,7; Total score; 0-12 Vomiting Experience Questions: 1,3,6; Total score; 0-12 Retching Experience Questions: 2,8; Total score; 0-8 Occurence (total occurence score; 20): Nausea Occurence Questions: 4,7; Total score; 0-8 Vomiting Occurence Questions: 1, 6; Total score; 0-8 Retching Occurence Questions: 8; Total score; 0-4 Distress (total occurence score; 12): Nausea Distress Questions: 5; Total score; 0-4 Vomiting Distress Questions: 3; Total score; 0-4 Retching Distress Questions: 2; Total score; 0-4

  Early postoperative period; 0-6 hours after surgery

• The Comparison of PONV Occurence by total R-INVR Scores in the Intervention and Control Groups

  PONV measure; Any R-INVR total score above zero (\>0) indicates that participant experienced nausea. This results were compared in control and intervention groups.

  Early postoperative period; 0-6 hours after surgery

• The Comparison of PONV Intensity by Total score of R-INVR (0-32 points) in the Intervention and Control Groups

  R-INVR scale total score was summed; higher points indicate worse nausea and/or vomiting Each response is scored between 0 to 4, and the score from 8 items were summed. The worst PONV experience can be expressed with the highest value of 32 points. These scores were compared in control and intervention groups and analysed.

  Early postoperative period; 0-6 hours after surgery

• The Comparison Between R-INVR Average Scores in the Intervention and Control Groups

  R-INVR scale total score was averaged in groups (total score0-32 points by 8 items each 0-4 points) (control, intervention); higher score indicates worse nausea and/or vomiting within the group

  Early postoperative period; 0-6 hours after surgery

• The Comparison of R-INVR Average Scores by the Intervention and Control groups

  R-INVR scale averaged scores were compared in groups (control, intervention); higher score indicates worse nausea and/or vomiting within the group.

  Early postoperative period; 0-6 hours after surgery

• Visual Analog Scale (VAS) (0-10 points) for PONV

  The level of experienced nausea and vomiting described by participants and nurses using VAS; 10 indicates the worst experience of nausea and/or vomiting; and 0, no nausea or vomiting being experienced

  Early postoperative period; 0-6 hours after surgery

Secondary Outcomes (8)

• Anesthesia duration by minutes (marked as sign in and time out) and PONV occurence (R-INVR total score) comparison

  Early postoperative period; 0-6 hours after surgery

• The Comparison of Smoking status (smoking or not smoking) of Participants in the Intervention and Control Groups was compared with PONV occurence (R-INVR total score)

  Early postoperative period; 0-6 hours after surgery

• The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants

  Early postoperative period; 0-6 hours after surgery

• The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants in the Intervention and Control Groups

  Early postoperative period; 0-6 hours after surgery

• The Comparison of the Intensity of PONV Occurence in PONV risk groups (not smoking, women, age <50, over one hour anesthesia, previous experience of PONV or motion sickness) by the total R-INVR scores

  Early postoperative period; 0-6 hours after surgery

Study Arms (4)

Intervention Lap.Chol.

EXPERIMENTAL

Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a laparoscopic cholecystectomy.

Dietary Supplement: Honey and water mixture

Control Lap.Chol.

NO INTERVENTION

The participants received standard care for their laparoscopic cholecystectomy.

Intervention Thyroidectomy

EXPERIMENTAL

Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a thyroidectomy.

Dietary Supplement: Honey and water mixture

Control Thyroidectomy

NO INTERVENTION

The participants received standard care for their thyroidectomy.

Interventions

Honey and water mixture DIETARY_SUPPLEMENT

60 gr of organic Turkish BlackSea Region Chestnut Honey and 100 ml Spring water mixture both mixed in room temperature and ingested up to two hours before the surgery by participants who were "nill by mouth" from midnight prior to the operation day.

Intervention Lap.Chol.; Intervention Thyroidectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who volunteered to participate in the study
• Individuals who have the ability to make decisions
• Thyroidectomy operation
• Laparoscopic cholecystectomy (Lap. Chol.) operation
• Individuals who score 2/5 or more out of the Koivuranta PONV risk factors\*

You may not qualify if:

• Patients with diabetes,
• Nothing by mouth patients (for other reasons than surgery),
• Gastrointestinal system surgery patients
• Individuals with pollen allergy
• Koivuranta PONV risk factors:
• Female gender, Non-smoking individuals History of PONV History of motion sickness Anesthesia duration

Sponsors & Collaborators

• OYA GUMUSKAYA BRADLEY: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Honey

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• OYA GUMUSKAYA, PhD

  Yeditepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded regarding which gastrointestinal complication was going to be evaluated after the surgery. Participants were informed that the intervention was for postoperative gastrointestinal comfort, without nausea and vomiting being mentioned in order to avoid psychological leading to PONV. The nurses who collected the data were blinded for the group information (intervention or control) though they were informed the days of participant allocation (each morning they were informed that the current operating list included participants) for the proper use of the data collection forms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial with two types of surgery compared, each consisting intervention and control groups.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 24, 2019
• Study Start: May 3, 2017
• Primary Completion: January 9, 2018
• Study Completion: February 19, 2018
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 2 years from publication of all results.
• Access Criteria: Contact to investigators.

Locations

TU (1)