Anesthesia Clinical Trial
— SPIGERASOfficial title:
Impact of General Anesthesia v/s Spinal Anesthesia on Enhanced Recovery After Surgery (ERAS) Parameters in Intestinal Stoma Reversal: A Randomised Control Trial
Randomized, Interventional ,Open labeled, Parallel Assignment and Superiority trial.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age of the patient ;18 years - Patients with Loop stoma, Double Barrel Stoma or End stoma with - documented hitched distal loop. - Patients evaluated and fit for surgery Exclusion Criteria: - Patients requiring mid line laparotomy for stoma reversal - Patient having active stoma related complications like high output stoma - and dehydration - Acute Kidney Injury, stoma prolapse, etc making them - unfit for surgery. - Patient denying consent for SA or ERAS protocol - Patient having contraindication for either type of anaesthesia (where - randomisation would not be possible) - Patient needing to be converted to GA after pain /discomfort experienced - by patient or if there was failed spinal anaesthesia - Patient having abnormal coagulation profile - Coexistent neurological or psychiatric illness or unable to understand the - study. |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences, | Bhubaneswar | Odisha |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, Bhubaneswar |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Postoperative mean Numerical Rating Score | Postoperative pain score will be estimated. Numerical Rating Score will be used- Minimum 0 and Maximum 10 | At 6,12 and 24 hours | |
Other | Time to need 1st injectable rescue analgesic i.e. Tramadol | Time of requirement of rescue analgesics from the time of patient leaving operating room up to 72 hours after surgery will be estimated in hours | Up to 72 hours after surgery | |
Other | Total number of doses of rescue analgesic used | Total number of doses of rescue analgesics used from the time of patient leaving operating room up to 1 week after surgery will be calculated | Up to 1 week after surgery | |
Other | Surgeon's and patient satisfaction by Local Experienced Discomfort Score | Degree of satisfaction of the surgeon and the patient for the procedure performed from the time of incision to time of completion of skin closure will be noted. Local Experienced Discomfort Score will be used- Minimum 0 and Maximum 10 | Intraoperative, From the time of incision to time of completion of skin closure | |
Other | Percentage of times there is a need of conversion of Spinal Anesthesia to General Anesthesia intraoperative pain or severe discomfort to the patient | Number of times there was need to administer General anesthesia in procedures under spinal anesthesia | Intraoperative, From the time of patient entering operating room to leaving operating room | |
Other | Percentage of times there is a need for ICU admission for anesthesia recovery related issues | Number of times postoperative ICU stay from the time of patient leaving operating room up to 24 hours after surgery | Immediately after the intervention, Up to 24 hours after surgery | |
Other | Duration of post-operative hospital stay | Length of hospital stay from the time of patient leaving operating room up to discharge | Immediately after the intervention | |
Other | Complications and its incidence: ileus, need for RT insertion or readmission, anastomotic leak ( in terms of Clavein Dindo Classification) | Any complication after surgery will be noted | Postoperative, Upto 30 days from surgery | |
Other | Time to walk around independently | Time to start ambulation from the time of patient leaving operating room up to 72 hours after surgery will be noted in hours | Up to 72 hours after surgery | |
Other | Duration of Surgery | Duration of Surgery from the time of incision to time of completion of skin closure will be noted in hours | From the time of incision to time of completion of skin closure | |
Other | Duration of Stay in Operating Room | Duration of Stay in Operating Room from the time of patient entering operating room to leaving operating room will be recorded in hours | From the time of patient entering operating room to leaving operating room | |
Primary | Time to passage of flatus | Time to passage of first flatus from the time of patient leaving operating room up to 72 hours after surgery will be estimated in hours | Up to 72 hours after surgery | |
Secondary | Time to passage of motions | Time to passage of first stool from the time of patient leaving operating room up to 1 week after surgery in hours will be estimated | Up to 1 week after surgery | |
Secondary | Time taken to resumption of oral intake | Time to resume the first oral intake from the time of patient leaving operating room up to 72 hours after surgery will be estimated in hours | Up to 72 hours after surgery | |
Secondary | Time of complete stoppage of IV fluids | Time to completely stop the administration of intravenous fluids from the time of patient leaving operating room up to 72 hours after surgery will be estimated in hours | Up to 72 hours after surgery |
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