To study stress response in children undergoing laparoscopic surgery.

To study salivary cortisol as a surrogate marker of stress response in children undergoing laparoscopic surgery with low- pressure vs high-pressure pneumoperitoneum : a randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075869

Enrollment

Registered

2024-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis Health Condition 2: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities Health Condition 3: K00-K95- Diseases of the digestive system Health Condition 4: N00-N99- Diseases of the genitourinary system Health Condition 5: S00-T88- Injury, poisoning and certain other consequences of external causes

Interventions

Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1-12 years undergoing laparoscopic surgery

Exclusion criteria

Exclusion criteria: Children with underlying adrenal pathologies e.g. adrenal tumors, congenital adrenal hyperplasia (CAH), etc. Children on steroid therapy Children undergoing laparoscopic surgery for acute inflammatory conditions like appendicitis, Meckel’s diverticultis etc. Refusal of parental consent for participation in the study

Design outcomes

Primary

Measure	Time frame
The primary outcome measures are pre-operative and post-operative salivary cortisol levels in the two study groups.Timepoint: Pre-operatively. at 6 hours post surgery, at 12 hours post surgery, at 24 hours post surgery, at 48 hours post surgery, at 72 hours post surgery.	—

Secondary

Measure	Time frame
Secondary outcome measures are HR, MAP, EtCO2 during surgery at different time points as mentioned earlier, duration of the surgery, length of hospital stay, time to resume feeds, post-operative pain & analgesia requirementTimepoint: HR, MAP AND EtCO2 will be recorded, before CO2 insufflation (T0), 20 min after insufflation (T1), before desufflation (T2), & 10 min after desufflation (T3) Pain will be assessed at POD-1 & POD-2	—

Measure

Time frame

Secondary outcome measures are HR, MAP, EtCO2 during surgery at different time points as mentioned earlier, duration of the surgery, length of hospital stay, time to resume feeds, post-operative pain & analgesia requirementTimepoint: HR, MAP AND EtCO2 will be recorded, before CO2 insufflation (T0), 20 min after insufflation (T1), before desufflation (T2), & 10 min after desufflation (T3) Pain will be assessed at POD-1 & POD-2

—

Countries

India

Contacts

Public ContactDr Nishant Agarwal

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

nishantagarwal22121993@gmail.com09458705175

Outcome results

None listed

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