The effect of water or a carbohydrate drink on patient discomfort and satisfaction before elective gynaecology surgery

ISRCTN	ISRCTN89731226
DOI	https://doi.org/10.1186/ISRCTN89731226
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2021323-9975
Sponsor	Pusat Perubatan Universiti Malaya
Funder	Pusat Perubatan Universiti Malaya

Submission date: 12/05/2021
Registration date: 17/05/2021
Last edited: 31/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of this study is to evaluate the effects of free access to water compared to free access to carbohydrate drink before surgery on discomfort, satisfaction and recovery. The study is important to show the difference in the outcome between both these groups to help improve practice in future.

Who can participate?
Women aged over 18 undergoing elective gynaecological surgery under general anaesthetic

What does the study involve?
Participants are allocated at random (by chance alone) to receive either carbohydrate drink or water until operation theatre (OT) call time. Questionnaires are used to assess discomfort, satisfaction and recovery after surgery. Participants will be involved in this study from 12 midnight from the day of the operation until discharge from hospital.

What are the possible benefits and risks of participating?
There may or may not be any benefits to participants. Information obtained from this study will help improve standard practice for women going for elective gynaecological surgery. Both drinks are expected to be safe as the guidelines indicate patients are allowed clear fluids up to 1 hour before surgery and based on a recent study the risk of stomach contents entering the lungs is low. Patients will be assessed from time to time and if required they will be started on intravenous fluids. Patients may have a very small risk of vomiting; those patients will be monitored and medication to prevent and stop vomiting will be given accordingly.

Where is the study run from?
Pusat Perubatan Universiti Malaya (Malaysia)

When is the study starting and how long is it expected to run for?
March 2021 to June 2022

Who is funding the study?
Pusat Perubatan Universiti Malaya (Malaysia)

Who is the main contact?
Dr Nantharuban Rajoo
nan_2403@yahoo.com.sg

Contact information

Dr Nantharuban Rajoo
Scientific

1609 Jalan 18/46, Taman Sri Serdang
Seri Kembangan
43300
Malaysia

Phone	+60 (0)17614121
Email	nantharuban@ummc.edu.my

Study information

Primary study design	Interventional
Study design	Open-label single-centre prospective randomized controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN89731226_PIS_v1_25Mar2021.pdf
Scientific title	Preoperative oral water as opposed to free access to oral carbohydrate drink in elective gynaecology surgery: a randomised trial
Study objectives	Patients who are allowed a carbohydrate drink until operating theatre (OT) call time have improved discomfort and satisfaction.
Ethics approval(s)	Approved 10/05/2021, Medical Research Ethics Committee, University of Malaya Medical Centre (Jln Profesor Diraja Ungku Aziz, 59100 Kuala Lumpur, Malaysia; +60 (0)3 7949 3209/2251; iresearch@ummc.edu.my), ref: 2021323-9975
Health condition(s) or problem(s) studied	Elective gynaecology surgery
Intervention	Participants will receive usual care. Prior to the operation they will be seen by the anaesthetic team and assessed after which they will be given a date for elective admission to the ward 1 day prior to the surgery. Final eligibility for entry to the study will only be done on the day of admission 1 day prior to the operation. In the ward after being assessed by the anaesthetic team and the gynaecology team in charge and confirmed for operation the next day. At this point they will be given a sealed envelope with a number which will determine the study protocol they need to follow, either free access to water or free access to a carbohydrate drink until their operating theatre (OT) call time.
Intervention type	Other
Primary outcome measure(s)	1. Hunger measured using verbal numerical rating scale (VNRS) 0 to 10 at OT call time 2. Patient satisfaction measured using VNRS 0 to 10 at OT call time
Key secondary outcome measure(s)	Current secondary outcome measures as of 11/01/2022: 1. Measured using a questionnaire: 1.1. Feeling thirsty at OT call time measured using a verbal numerical rating scale (VNRS) 0 to 10 at OT call time (baseline) 1.2. Feeling nauseous at OT call time measured using verbal numerical rating scale VNRS 0 to 10 OT call time (baseline) 1.3. Vomiting (yes or no) measured at OT call time and at first oral feed postoperatively (baseline) 2. Capillary blood sugar measured using a capillary blood glucose monitoring device at OT call time (baseline) 3. Measured using urine dipstick at OT call time (baseline) 3.1. Ketonuria: nil, 1+, 2+, 3+, 4+ at OT call time (baseline) 3.2. Glycosuria: nil, 1+, 2+, 3+, 4+ at OT call time (baseline) 4. Post-general anesthesia (GA) to intraoperative interval: blood pressure pre GA (baseline), lowest intraoperative blood pressure measured on an automated blood pressure monitoring device, medication needed to maintain blood pressure in OT prior to intubation measured using medical records 5. Usage of antiemetics measured using chart on drug dosage and number of times administered preoperative, intraoperative and postoperative 6. Post-operation time to first oral feed and first flatus measured using medical records at baseline 7. Resting pain score measured using VNRS 0 to 10 on day 1 before mobilization (baseline) 8. Interval from surgery to ambulation measured using medical records at baseline 8.1. Post-operation time to sitting up, measured at baseline 8.2. Post-operation time to walking, measured at baseline 8.3. Passing urine for the first time after removal of catheter, measured at baseline 9. Fever (≥38°C) measured using medical records postoperatively (baseline) 10. Operation to discharge interval: number of days of admission measured using medical records 11. Major complications measured using medical records postoperatively 11.1. ICU admission: yes/no - number of days of admission 11.2. Aspiration pneumonitis: yes /no 11.3. Mallory Weiss tear: yes /no Previous secondary outcome measures: 1. Measured using a questionnaire: 1.1. Feeling thirsty at OT call time measured using a verbal numerical rating scale (VNRS) 0 to 10 at 0 hours (at OT call time) 1.2. Feeling nauseous at OT call time measured using verbal numerical rating scale VNRS 0 to 10 at 0 hours (at OT call time) 1.3. Vomiting (yes or no) measured at OT call time (0 hours), 6 hours, 12 hours and 24 hour postoperative 2. Capillary blood sugar measured using a capillary blood glucose monitoring device at 0 hours (at OT call time) 3. Measured using urine dipstick pre- and post-operatively: 3.1. Ketonuria: nil, 1+, 2+, 3+, 4+ at 0 hours and postoperative 6 hours 3.2. Glycosuria: nil, 1+, 2+, 3+, 4+ at 0 hours and postoperative 6 hours 4. Post-general anesthesia (GA) to intraoperative interval: blood pressure pre GA (baseline), lowest intraoperative blood pressure measured on an automated blood pressure monitoring device, medication needed to maintain blood pressure in OT prior to intubation measured using medical records 5. Usage of antiemetics measured using chart on drug dosage and number of times administered preoperative, intraoperative and postoperative 6. Post-operation time to first oral feed and first flatus measured using medical records at 0 hours, 6 hours, 12 hours, 24 hours. 7. Resting pain score measured using VNRS 0 to 10 at 0 hours, 6 hours, 12 hours and on day 1 before mobilization 8. Interval from surgery to ambulation measured using medical records 8.1. Sitting up (time 0 hours, 6 hours, 24 hours) 8.2. Walking (time 0 hours, 6 hours, 24 hours) 8.3. Passing urine for the first time after removal of catheter (time 0 hours, 6 hours, 24 hours) 9. Fever (≥38°C) measured using medical records at 0 hours, 6 hours, 12 hours and 24 hours post-operative 10. Operation to discharge interval: number of days of admission measured using medical records 11. Major complications measured using medical records at 0 hours, 6 hours and 24 hours 11.1. ICU admission: yes/no - number of days of admission 11.2. Aspiration pneumonitis: yes /no 11.3. Mallory Weiss tear: yes /no
Completion date	30/06/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	260
Key inclusion criteria	1. Patients planned for elective gynecology surgery 2. Age more than 18 years old 3. Receiving general anesthesia 4. Body Mass Index (BMI) <35 kg/m² 5. ASA I-II
Key exclusion criteria	1. BMI >35 kg/m² 2. Abdominal mass >28 weeks palpable 3. Gastroesophageal reflux disease 4. H/O gastrointestinal surgery 5. Emergency gynecology surgery 6. Type 1 and type 2 diabetes mellitus 7. Psychiatric disorder (unable to give consent) 8. Anticipated ICU admission 9. Anticipated difficult Intubation 10. Suspected COVID-19 infection or COVID-19 positive
Date of first enrolment	24/05/2021
Date of final enrolment	31/05/2022

Locations

Countries of recruitment

Malaysia

Study participating centre

Pusat Perubatan Universiti Malaya

Jln Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version v1	25/03/2021	01/06/2021	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file			01/06/2021	No	No
Protocol file	version 2		24/01/2022	No	No
Protocol file	version 3		31/01/2022	No	No

Additional files

ISRCTN89731226_PIS_v1_25Mar2021.pdf: Uploaded 01/06/2021
ISRCTN89731226_PROTOCOL.pdf: Uploaded 01/06/2021
ISRCTN89731226_PROTOCOL_V2.pdf: Protocol file
ISRCTN89731226_PROTOCOL_V3.pdf: Protocol file

Editorial Notes

31/01/2022: Uploaded protocol file (not peer reviewed).
24/01/2022: Uploaded protocol file (not peer reviewed).
11/01/2022: The secondary outcome measures were updated.
01/06/2021: The following changes have been made:
1. Uploaded protocol file (not peer reviewed).
2. The participant information sheet has been uploaded as an additional file.
17/05/2021: Medical Research Ethics Committee, University of Malaya Medical Centre.