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Clinical trial to study the effect of oral carbohydrate solution given before surgery in women undergoing elective Caesarean delivery under spinal anesthesia.

Randomized control trial to study the effect of oral carbohydrate on preoperative well being ,intra operative hypotension and postoperative recovery in women undergoing elective cesarean delivery under spinal anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038230
Enrollment
100
Registered
2021-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Group 1 Carbohydrategroup (CHO): Oral carbohydrate group will receive 400 ml of fluid containing 50 g of carbohydrate 2-4 hours before surgery. Control Intervention1: Group 2 Plain wate

Sponsors

Directorate of Medical Education Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Full-term pregnancy (>=37 weeks estimated gestational age) Singleton gestation

Exclusion criteria

Exclusion criteria: 1) Pre-gestational or gestational diabetes 2) Incomplete gestational diabetes screening 3) History of steroid administration within 7 days prior to planned delivery 4) History of magnesium sulphate administration because of hypertensive disorder of pregnancy 5) Current opioid use 6)Foetus with congenital anomalies or growth restriction 7) American Society of Anaesthesiology physical class III or greater

Design outcomes

Primary

MeasureTime frame
Preoperative well being Visual analogue scale (VAS) for hunger, thirst, anxiety, fatigue, and nausea administered on the morning of surgery. Timepoint: In the preopeartive room prior to surgery.

Secondary

MeasureTime frame
Incidence of post-spinal hypotension â?? systolic blood pressure of less than 100mmHg or decrease in more than 20% of baseline. Timepoint: Intraoperative after spinal anesthesia. ;Blood sugar level of patient immediate before surgery and on Day 1 post-operative.Timepoint: Prior to surgery and fasting blood sugar in the morning on postoperative day 1;Cord blood sugar estimationTimepoint: Immediately after delivery;Incidence of intra operative nausea & vomitingTimepoint: Intraoperative;Post-operative satisfaction as measured by Quality of Recovery from Anaesthesia questionnaire(QoR-40)Timepoint: Post operatively 24 hours after suregry.;Total Phenylephrine useTimepoint: Intraoperative

Countries

India

Contacts

Public ContactSunil Thakur

Dr.RKGMC Hamirpur

sunil2044@gmail.com9805657716

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026