Effect of Different Fresh Gas Flows on Hypothermia Among Neonates Undergoing Surgery.

Minimal versus Standard Fresh Gas Flow and Intraoperative Hypothermia in Neonates Undergoing Abdominal Surgery: A Randomized Controlled Trial - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109412

Enrollment

100

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: K20-K31- Diseases of esophagus, stomach and duodenum Health Condition 2: K55-K64- Other diseases of intestines

Interventions

Intervention1: Group M- Minimal flow group (0.5 L/min): Patients will receive a flow rate of 0.5 L/minute during the surgery after Induction of Anaesthesia. Control Intervention1: Group C- Control gro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 0 to 28 days of life 2. Gestational age more than 34 weeks 3. Birthweight more than 2 kg 4. Undergoing abdominal surgeries under general anesthesia 5. Elective/emergency surgeries

Exclusion criteria

Exclusion criteria: 1. Gestational age less than or equal to 34 weeks 2. Neonates with pre-existing fever (more than 37.5 C), hypothermia (less than 34 C) 3. Hemodynamically unstable or under more than one vasopressor 4. Diagnosed hypothyroidism/hyperthyroidism 5. Refusal by the parents to give consent

Design outcomes

Primary

Measure	Time frame
To compare the incidence of intraoperative hypothermia between the minimal flow group receiving 0.5 L/min fresh gas flow and the routine group receiving 2L/min gas flow.Timepoint: Anytime from the induction of Anaesthesia to the end of Surgery will be continuously measured.	—

Secondary

Measure	Time frame
1. To compare the mean intraoperative core temperature between the groups 2. To compare the change in Tc from baseline till the end of the procedure between the 2 groups. 3. To compare the proportion of total surgical time spent under hypothermia 4. To compare time to resume nasogastric/ oral feeds & removal of nasogastric tube 5. To compare post-operative outcomes, including duration of elective mechanical ventilation (days), ICU stay, total hospital stay & in-hospital mortality between the groups 6. To compare hemodynamic parameters between the groups 7. Consumption of inhalational agent agents Timepoint: The time from the induction of anaesthesia until death/discharge from the hospital will be measured every day after surgery.	—

Measure

Time frame

1. To compare the mean intraoperative core temperature between the groups 2. To compare the change in Tc from baseline till the end of the procedure between the 2 groups. 3. To compare the proportion of total surgical time spent under hypothermia 4. To compare time to resume nasogastric/ oral feeds & removal of nasogastric tube 5. To compare post-operative outcomes, including duration of elective mechanical ventilation (days), ICU stay, total hospital stay & in-hospital mortality between the groups 6. To compare hemodynamic parameters between the groups 7. Consumption of inhalational agent agents Timepoint: The time from the induction of anaesthesia until death/discharge from the hospital will be measured every day after surgery.

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Countries

India

Contacts

Public ContactAjay Singh

Post Graduate Institute of Medical Education and Research, Chandigarh, India

ajay.ydv2509@gmail.com09999276845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026